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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01750190
Registration number
NCT01750190
Ethics application status
Date submitted
11/12/2012
Date registered
17/12/2012
Date last updated
1/10/2021
Titles & IDs
Public title
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
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Scientific title
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
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Secondary ID [1]
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FGCL-4592-060
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
CKD Anemia
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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Other renal and urogenital disorders
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Blood
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0
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Anaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Roxadustat
Treatment: Drugs - Placebo
Experimental: Roxadustat - Participants will receive roxadustat tablets orally 3 times a week (TIW). The initial dose will be according to the tiered weight-based approach, with starting roxadustat doses of 70 milligrams (mg) TIW to participants weighing <70 kilograms (kg) and roxadustat doses of 100 mg TIW to participants weighing =70 kg. Dose-titration (up to a maximum dose of 300 mg) will be performed based upon regular measurement of Hb levels until the participant achieves central Hb value of =11.0 grams/deciliter (g/dL) and Hb increase from baseline (BL) of =1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level is reached, the participant will enter the maintenance period during which roxadustat dosage will be adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration will be up to 234.9 weeks.
Placebo Comparator: Placebo - Participants will receive roxadustat-matching placebo tablets orally TIW. The initial dose will be according to the tiered weight-based approach, with starting roxadustat-matching placebo doses of 70 mg TIW to participants weighing <70 kg and roxadustat-matching placebo doses of 100 mg TIW to participants weighing =70 kg. Dose-titration (up to a maximum dose of 300 mg) will be performed based upon regular measurement of Hb levels until the participant achieves central Hb value of =11.0 g/dL and Hb increase from BL of =1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level is reached, the participant will enter the maintenance period during which roxadustat dosage will be adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration will be up to 208.1 weeks.
Treatment: Drugs: Roxadustat
Oral tablets
Treatment: Drugs: Placebo
Oral tablets
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy
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Assessment method [1]
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The change in Hb from baseline to the average level during the evaluation period (defined as Week 28 until Week 52) is reported. Hb values under the influence of a rescue therapy were not censored. The intermittent missing hemoglobin data were imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model, Monotone missing data were imputed by regression from its own treatment group. Baseline Hb was defined as the mean of up to 4 last central laboratory values prior to the first dose of study drug.
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Timepoint [1]
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Baseline (Day 1, Week 0), Weeks 28 to 52
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Primary outcome [2]
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Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy
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Assessment method [2]
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The number of participants who achieved a Hb response at 2 consecutive visits at least 5 days apart during the first 24 weeks of treatment, without rescue therapy (that is, red blood cell [RBC] transfusion, erythropoiesis-stimulating agent [ESA], or intravenous [IV] iron) are reported. A Hb response is defined, using central laboratory values, as the following:
Hb =11 g/dL and Hb increase from baseline by =1 g/dL in participants with baseline Hb >8 g/dL, or
An increase in Hb by =2 g/dL in participants with baseline Hb =8.0 g/dL
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Timepoint [2]
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Baseline up to Week 24
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Secondary outcome [1]
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Mean Change From Baseline in Hb Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy
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Assessment method [1]
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For Ex-US submission only: Hb values under the influence of a rescue therapy were censored by mixed effect model of repeated measures (MMRM) for up to 6 weeks. Baseline Hb was defined as the mean of up to 4 last central laboratory values prior to the first dose of study drug.
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Timepoint [1]
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Baseline (Day 1, Week 0), Weeks 28 to 36
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Secondary outcome [2]
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Mean Change From Baseline in Hb Averaged Over Weeks 28 to 52 Regardless of Rescue Therapy in Participants With Baseline C-Reactive Protein (CRP) >Upper Limit of Normal (ULN)
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Assessment method [2]
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Hb values under the influence of a rescue therapy were not censored in the analysis. The intermittent missing hemoglobin data were imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model, Monotone missing data were imputed by regression from its own treatment group. Baseline Hb was defined as the mean of up to 4 last central laboratory values prior to the first dose of study treatment.
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Timepoint [2]
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Baseline (Day 1, Week 0), Weeks 28 to 52
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Secondary outcome [3]
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Number (%) of Participants With Hb =10 g/dL Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy
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Assessment method [3]
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Hb values under the influence of a rescue therapy were censored by Cochran-Mantel-Haenszel Test for up to 6 weeks. Responder was defined as: Hb =10.0 g/dL, which was based on central laboratory values.
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Timepoint [3]
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Weeks 28 to 36
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Secondary outcome [4]
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Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 28
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Assessment method [4]
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Baseline LDL cholesterol was defined as the last LDL cholesterol value prior to the first dose of study drug.
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Timepoint [4]
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Baseline (Day 1, Week 0), Weeks 12 to 28
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Secondary outcome [5]
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Rate of Change in eGFR From Baseline up to 12 Months (Linear Random Coefficient Model With Observed Data)
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Assessment method [5]
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Progression of chronic kidney disease was measured by rate of change in eGFR over time adjusted by baseline eGFR, with censoring for chronic dialysis or kidney transplant, using random slope and intercept model. Least Square Mean of change from baseline at 1 year was derived based on a random slopes and intercepts model using all available eGFR values (1 baseline and all post-treatment values up to end of treatment period + 7 days or start of dialysis) adjusted on treatment, baseline Hb, baseline eGFR, geographical region, cardiovascular events history at Baseline (yes vs. no), time (continuous value), the interaction terms of baseline eGFR by time, baseline Hb by time, and treatment by time as fixed effects, with random effects of intercept and linear slope of time. All assessments collected after the start of stable dialysis or kidney transplant were excluded from the analysis.
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Timepoint [5]
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Baseline, Month 12
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Secondary outcome [6]
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Number of Participants Who Received Blood/RBC Transfusion in the First 52 Weeks of Treatment
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Assessment method [6]
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Participants with any use of blood/RBC transfusion were reported.
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Timepoint [6]
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Baseline up to Week 52
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Secondary outcome [7]
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Number (%) of Participants Who Received Rescue Therapy in the First 24 Weeks and in the First 52 Weeks of Treatment
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Assessment method [7]
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Rescue therapy included any use of RBC transfusion, ESA, or IV iron.
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Timepoint [7]
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Baseline (Day 1, Week 0) up to Week 24 and up to Week 52
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Secondary outcome [8]
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Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 12 to 28
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Assessment method [8]
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The SF-36 V2 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The physical functioning subscore and vitality subscore are reported. The scores ranged from 0 (worst) to 100 (Best). A higher score indicates a general improvement of life quality or well-being. Baseline score was defined as the last physical functioning value or vitality value, as applicable, prior to the first dose of study drug.
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Timepoint [8]
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Baseline (Day 1, Week 0), Weeks 12 to 28
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Secondary outcome [9]
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Number (%) of Participants Who Experienced Exacerbation of Hypertension
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Assessment method [9]
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Exacerbation of hypertension was defined as an increase from baseline of =20 millimeter of mercury (mmHg) in systolic blood pressure (sBP) and sBP =170 mmHg or an increase from baseline of =15 mmHg in diastolic blood pressure (dBP) and dBP =110 mmHg.
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Timepoint [9]
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Baseline up to Week 52
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Secondary outcome [10]
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Mean Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 20 to 28
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Assessment method [10]
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Baseline MAP was defined as the last MAP value prior to the first dose of study drug.
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Timepoint [10]
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Baseline, Weeks 20 to 28
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Eligibility
Key inclusion criteria
- Chronic kidney disease Stages 3, 4, or 5 and not receiving dialysis
- Anemia qualified by measurements of hemoglobin values during screening
- Additional blood work must be in a safe range for study entry
- Body weight 45 to 160 kilograms (kg)
- Willingness to use contraception if of child-bearing potential
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to
study participation
- More than 1 dose of intravenous iron within 12 weeks prior to study participation
- Blood transfusion within 8 weeks prior to study participation
- Active infection
- Chronic liver disease
- Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot
- Uncontrolled blood pressure within 2 weeks prior to study participation
- Renal cell carcinoma
- History of malignancy, including multiple myeloma or other myelodysplastic syndrome
- Chronic inflammatory disease that could impact red blood cell production
- Any prior organ transplant or a scheduled organ transplantation
- Anticipated elective surgery that is expected to lead to significant blood loss or
anticipated elective heart procedure
- Gastrointestinal bleeding
- Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase
inhibitor (HIF-PHI)
- Recent use of an investigational drug or treatment, or participation in an
investigational study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/11/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/09/2018
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Sample size
Target
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Accrual to date
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Final
922
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Investigational Site - Liverpool
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Investigational Site - Gosford
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Investigational Site - Hobart
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Investigational Site - Launceston
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Investigational Site - Melbourne
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Recruitment hospital [6]
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Investigational Site - New Lambton Heights
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Recruitment hospital [7]
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Investigational Site - Randwick
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2250 - Gosford
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Recruitment postcode(s) [3]
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7000 - Hobart
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Recruitment postcode(s) [4]
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7250 - Launceston
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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2305 - New Lambton Heights
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Recruitment postcode(s) [7]
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2031 - Randwick
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Recruitment outside Australia
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Provincia De Cordoba
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Gyeonggi-Do
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Kajang
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Taiping
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Hamilton
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Lima
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Cavite
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Ponce
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Singapore
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Changhua
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Hualien City
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Kaohsiung
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
FibroGen
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Astellas Pharma Europe B.V.
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Address [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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AstraZeneca
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Address [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether roxadustat is safe and effective in the
treatment of anemia in participants with chronic kidney disease and not on dialysis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01750190
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mark Eisner, MD, MPH
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Address
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FibroGen
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01750190
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