Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02469467




Registration number
NCT02469467
Ethics application status
Date submitted
1/06/2015
Date registered
11/06/2015
Date last updated
8/02/2016

Titles & IDs
Public title
A Dose Escalation Study of VS-505 in End Stage Renal Disease Patients Undergoing Hemodialysis
Scientific title
A Dose Escalation Study of VS-505 to Evaluate the Tolerability, Safety and Efficacy in End Stage Renal Disease Patients Undergoing Hemodialysis
Secondary ID [1] 0 0
VDKDL001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Disease 0 0
Hyperphosphatemia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - VS-505

Experimental: VS-505 - 750 mg capsule


Other interventions: VS-505
VS-505 is orally administered with meal for 8 weeks
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Inorganic phosphorus (Pi) change from baseline to end of treatment
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Calcium (Ca) change from baseline to end of treatment
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Ca x Pi change from baseline to end of treatment
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
intact parathyroid hormone change from baseline to end of treatment
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Rate of patients whose Pi reduction is 0.65 mmol/L (2.0 mg/dL)
Timepoint [4] 0 0
8 weeks
Secondary outcome [5] 0 0
Rate of patients whose Pi reaches the goal between 1.13 mmol/L (3.5 mg/dL) and 1.94 mmol/L (6.0 mg/dL)
Timepoint [5] 0 0
8 weeks

Eligibility
Key inclusion criteria
- Written informed consent given

- Able to comply with the study procedures and medications

- On a stable hemodialysis (HD) regimen (3 times per week) including hemodialysis and
hemodiafiltration for =12 weeks at screening and during the study period

- No change in prescribed dose or frequency of any of the following medications within 4
weeks prior to screening

1. Injectable iron agents

2. Oral or injectable active vitamin D3

3. Oral nutritional vitamin D

4. Calcimimetics

5. Calcium supplements

6. Anti-osteoporotic medication including bisphosphonates

7. Calcitonins

- Must be willing to avoid intentional changes in diet throughout the study

- Women of child-bearing potential or non-sterile male subjects and those who are
sexually active with a non-sterile female partner must agree to use highly effective
contraception

- Plasma Pi level >1.94 mmol/L (6.0 mg/dL) to <3.23 mmol/L (10.0 mg/dL) after 2 weeks
washout will qualify patients to enter the treatment period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Blood purification therapy other than HD (hemodialysis and hemodiafiltration)

- The plasma Pi level is >2.26 mmol/L (7.0 mg/dL) within the latest three tests prior to
screening.

- Variation of the plasma Pi is over 0.65 mmol/L (2.0 mg/dL) within the latest three
tests prior to screening.

- Pre-emptive or scheduled renal transplant

- History of hemochromatosis or ferritin =1000 mcg/L

- Oral iron agents including prescribed and over-the-counter drugs at screening.

- Current clinically significant gastrointestinal (GI) disorder, including GI bleeding,
colitis, inflammatory bowel disease, irritable bowel syndrome, chronic constipation,
new diagnosis of peptic or duodenal ulcer disease, within 4 weeks prior to screening

- History of gastrectomy or duodenectomy, or GI tract surgery within 12 weeks prior to
screening

- Hypertension: Defined using pre-dialysis vital of diastolic blood pressure >110 mmHg
or systolic blood pressure >180 mmHg

- Possible parathyroid intervention including surgical parathyroidectomy and
percutaneous ethanol injection therapy during the study period

- Clinical evidence of active malignancy and/or receiving systemic
chemotherapy/radiotherapy with the exception of basal cell or squamous carcinoma of
the skin

- Severe cardiovascular disorders such as recent myocardial infarction; unstable angina;
congested heart failure (NYHA class II or above) hospitalized within 24 weeks (6
months), valve stenosis, atrial fibrillation and arrhythmia

- History of event by cerebrovascular disease or cardiovascular disease within 24 weeks
(6 months) prior to screening

- Active infection or current treatment with antibiotics within 2 weeks prior to
screening

- History of HIV (ELISA and Western blot) test results

- Known active liver disease with aspartate aminotransferase or alanine aminotransferase
levels greater than x3 the upper limit of normal

- Hepatitis B and/or hepatitis C treated with antiviral treatment within 4 weeks prior
to screening

- History of allergy of VS-505 and its related components

- Receipt of any investigational drug within 4 weeks prior to screening

- Pregnant and breast-feeding women

- Other patients who in the opinion of the investigators are ineligible for the study

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2016
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
LCR Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
KDL Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose is to evaluate the tolerability, safety and efficacy of VS-505 when given with
meal for 8 weeks to hemodialysis patients with hyperphosphatemia
Trial website
https://clinicaltrials.gov/ct2/show/NCT02469467
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johan Rosman, MD, Ph.D
Address 0 0
LCR Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
KDL inc
Address 0 0
Country 0 0
Phone 0 0
+81-3-3234-3400
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02469467