Study of Safety and Tolerability of BPS804 in Patients With Late-stage Chronic Kidney Disease
- Conditions
- Chronic-kidney Disease Stage 5D on Stable Hemodialysis
- Interventions
- Drug: Placebo
- Registration Number
- NCT01806610
- Lead Sponsor
- Ultragenyx Pharmaceutical Inc
- Brief Summary
The purpose of the study is to evaluate the safety, tolerability, and PK following a single administration of BPS804 in patients with chronic kidney disease stage 5D (CKD-5D) on hemodialysis.
- Detailed Description
This study was previously posted by Novartis and was transferred to Ultragenyx in February 2021.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BPS804 BPS804 Single dose BPS804 administration. Placebo Placebo Single dose placebo administration.
- Primary Outcome Measures
Name Time Method Occurrence of adverse events after a single administration of BPS804 17 weeks Adverse events will be counted within each treatment and study part. The numbers and percentages of adverse events will be tabulated by body system, preferred term, and severity.
- Secondary Outcome Measures
Name Time Method PK of BPS804 in serum: terminal elimination half-life Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing T1/2: The terminal elimination half-life
PK of BPS804 in serum: observed maximum serum concentration following drug administration Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing Cmax: The observed maximum serum concentration following drug administration
Pharmacokinetic (PK) of BPS804 in serum: area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing AUClast: The area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration
PK of BPS804 in serum: area under the serum concentration-time curve from time zero to infinity Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing AUCinf: The area under the serum concentration-time curve from time zero to infinity
PK of BPS804 in serum: time to reach the maximum concentration after drug administration Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing Tmax: The time to reach the maximum concentration after drug administration
Concentration of BPS804 in dialysate 48 hours after dosing Day 3, 48 hours post dosing Quantify BPS804 in dialysate 48 hours after dosing to assess any impact of dialysis on BPS804