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Clinical Trial Details

Trial ID: L1258
Source ID: NCT01806610
Associated Drug: Bps804
Title: Study of Safety and Tolerability of BPS804 in Patients With Late-stage Chronic Kidney Disease
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Chronic-kidney Disease Stage 5D on Stable Hemodialysis
Interventions: DRUG: BPS804|DRUG: Placebo
Outcome Measures: Primary: Occurrence of adverse events after a single administration of BPS804, 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., 17 weeks | Secondary: Pharmacokinetic (PK) of BPS804 in serum: area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration, AUClast: The 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|PK of BPS804 in serum: area under the serum concentration-time curve from time zero to infinity, AUCinf: The 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|PK of BPS804 in serum: observed maximum serum concentration following drug administration, Cmax: The 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|PK of BPS804 in serum: terminal elimination half-life, T1/2: The terminal elimination half-life, Pre-dose, and 2, 24, 44, 48, 168 hours and 15, 22, 29, 57, and 85 days after dosing|PK of BPS804 in serum: time to reach the maximum concentration after drug administration, Tmax: The 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|Concentration of BPS804 in dialysate 48 hours after dosing, Quantify BPS804 in dialysate 48 hours after dosing to assess any impact of dialysis on BPS804, Day 3, 48 hours post dosing
Sponsor/Collaborators: Sponsor: Ultragenyx Pharmaceutical Inc | Collaborators: Mereo BioPharma|Novartis
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-08
Completion Date: 2014-04
Results First Posted:
Last Update Posted: 2022-09-14
Locations:
URL: https://clinicaltrials.gov/show/NCT01806610