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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/NCT01200394
Registration number
NCT01200394
Ethics application status
Date submitted
10/09/2010
Date registered
13/09/2010
Date last updated
12/03/2019
Titles & IDs
Public title
A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
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Scientific title
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-DAILY ADMINISTRATION OF A PHOSPHODIESTERASE 5 INHIBITOR (PF-00489791) IN ADULTS WITH TYPE 2 DIABETES AND OVERT NEPHROPATHY
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Secondary ID [1]
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2010-021358-20
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Secondary ID [2]
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A7331011
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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:
Diabetic Nephropathies
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PF-00489791
Treatment: Drugs - Placebo
Experimental: PF-00489791 -
Placebo Comparator: Placebo -
Treatment: Drugs: PF-00489791
Tablet, 20 mg once daily for 12 weeks
Treatment: Drugs: Placebo
Tablet, placebo once daily for 12 weeks
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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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Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12
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Assessment method [1]
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UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units milligram per millimole (mg/mmol). A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of Week 12], and with last sample collected on the morning of scheduled clinic visit [Day 7 of Week 12]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.
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Timepoint [1]
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Baseline, Week 12 (Day 5, 6, 7)
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Secondary outcome [1]
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Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16
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Assessment method [1]
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UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units mg/mmol. A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of specified Week], and with last sample collected on the morning of scheduled clinic visit [Day 7 of specified Week]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.
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Timepoint [1]
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Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)
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Secondary outcome [2]
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Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16
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Assessment method [2]
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UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of Week 3, 6, 12, 16], and with last sample collected on the morning of scheduled clinic visit [Day 7 of Week 3, 6, 12, 16]) were used to determine UPCR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UPCR.
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Timepoint [2]
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Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 12 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)
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Secondary outcome [3]
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Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16
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Assessment method [3]
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The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration (sCr), age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) = 175*(sCr/88.4)^-1.154*(Age)^-0.203*(0.742 if female)*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1).
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Timepoint [3]
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Baseline, Week 3, 6, 12, 16 (follow-up)
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Secondary outcome [4]
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Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
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Assessment method [4]
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Systolic blood pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. diastolic blood pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. Mean blood pressure (MBP) = diastolic blood pressure + ([systolic blood pressure - diastolic blood pressure]/3). After a minimum of 5 minutes of rest, supine BP was measured with the participant's arm supported at the level of the heart.
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Timepoint [4]
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Week 0, 3, 6, 12, 16 (follow-up)
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Secondary outcome [5]
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Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16
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Assessment method [5]
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Serum creatinine concentration was used as a marker of renal function. Baseline serum creatinine concentration was determined predose at Week 0 (Day 1).
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Timepoint [5]
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Baseline, Week 3, 6, 12, 16 (follow-up)
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Secondary outcome [6]
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Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16
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Assessment method [6]
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TGF Beta-1 is a major fibrogenic growth factor implicated in the pathogenesis of renal scarring. It is overexpressed in the diabetic kidney where it may promote matrix accumulation. Baseline TGF Beta-1 concentration was determined predose at Week 0 (Day 1).
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Timepoint [6]
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Baseline, Week 3, 6, 12, 16 (follow-up)
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Secondary outcome [7]
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Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16
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Assessment method [7]
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The CRP is an acute phase reactant which is virtually absent from the blood serum of healthy persons but rapidly appears in blood and body fluids in response to injurious stimuli. Baseline hs-CRP was determined predose at Week 0 (Day 1).
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Timepoint [7]
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Baseline, Week 12, 16 (follow-up)
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Secondary outcome [8]
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Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16
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Assessment method [8]
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Cystatin C is produced by all nucleated cells at a constant rate and is freely filtered at the glomerulus. The blood concentration of cystatin C depends almost entirely on the GFR and is not substantially affected by diet, nutritional status or inflammatory disease. Serum cystatin C had been proposed as an endogenous marker of GFR in participant with chronic kidney disease (CKD) than sCr. Baseline serum cystatin C was determined predose at Week 0 (Day 1).
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Timepoint [8]
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Baseline, Week 12, 16 (follow-up)
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Secondary outcome [9]
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Plasma Concentration Versus Time Summary of PF-00489791
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Assessment method [9]
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Timepoint [9]
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Pre-dose at Day 1 of Week 0, 3, 6 and 12; 4 hours post-dose on Day 1 of Week 0, 3 and 6
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Eligibility
Key inclusion criteria
- Male or female subjects greater than or equal to 18 years. Female subjects must be of
non-child bearing potential.
- Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on
an eGFR of 25-59 mL/min/1.73m2.
- Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to
300 mg/g (greater than or equal to 33.9 mg/mmol) for greater than 3 months.
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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
- Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
- Subjects with poorly controlled diabetes mellitus, defined as HbA1C >9%.
- Subjects on combination ACE inhibitor/ARB therapy.
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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 analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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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
1/12/2010
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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
1/08/2013
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Sample size
Target
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Accrual to date
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Final
256
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Recruitment in Australia
Recruitment state(s)
NSW,NewcastleVIC
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Recruitment hospital [1]
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Renal Research Practice - Gosford
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John Hunter Hospital - Newcastle
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Department of Nephrology - New Lambton
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Recruitment hospital [4]
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Pharmacy Department - New Lambton
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Recruitment hospital [5]
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Melbourne Renal Research Group - Reservoir
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2250 - Gosford
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2305 - Newcastle
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2305 - New Lambton
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Recruitment postcode(s) [4]
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3073 - Reservoir
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Recruitment outside Australia
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791
will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure,
improving renal function.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01200394
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01200394
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