Study of Safety and Tolerability of BPS804 in Patients With Late-stage Chronic Kidney Disease

NCT01806610 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-09-14

No results posted yet for this study

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.

Conditions

  • Chronic-kidney Disease Stage 5D on Stable Hemodialysis

Interventions

DRUG

BPS804

Single dose BPS804 administration.

DRUG

Placebo

Single dose placebo administration.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Ultragenyx Pharmaceutical Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-04-30
Completion
2014-04-30

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01806610 on ClinicalTrials.gov