Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis
The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing fluid overload/weight gain between dialysis sessions for patients with End Stage Renal Disease on Hemodialysis.
End Stage Renal Disease
Chronic Kidney Disease Stage 5
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel Design Study to Evaluate the Pharmacodynamics, Safety, and Tolerability of AZD1722 in End-Stage Renal Disease Patients on Hemodialysis|
- Reduction in mean weekly interdialytic weight gain (IDWG) [ Time Frame: Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment) ] [ Designated as safety issue: No ]
- Stool sodium content [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: No ]
- Reduction in mean weekly IDWG [ Time Frame: Run-in period (Weeks -2 and -1) versus weeks 1, 2, and 3 and follow-up, weeks 5 and 6 ] [ Designated as safety issue: No ]
- Plasma concentrations of study drug [ Time Frame: Study Days 1, 3, 5, 7 and 29 ] [ Designated as safety issue: Yes ]
- Evaluate the safety and tolerability of 4 weeks of treatment [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: Yes ]AEs, SAEs, and safety laboratory evaluations.
|Study Start Date:||January 2013|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
doses between 5 and 90 mg may be administered based on tolerability
Other Name: RDX5791
|Placebo Comparator: Placebo|
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacodynamics of the study drug in male and female patients with end-stage renal disease on hemodialysis. The study consists of a 2 week treatment-free run-in period where entry criteria are verified, a 4-week treatment period, of which the first week of treatment will be performed as an in-patient study in a clinical pharmacology unit (CPU) and the remaining three weeks of treatment will performed as an out-patient study, and a 2-week treatment-free follow-up period.
Safety assessments will be performed at regular intervals and will include clinical and vital signs, clinical laboratory evaluations, ECGs, and AE monitoring. Pharmacodynamic assessments will include, but are not limited to, interdialytic weight gain (IDWG), blood pressure, and stool sodium excretion. Pharmacokinetic assessments will include blood sampling for measurement of study drug plasma concentrations.
|United States, Arizona|
|Southwest Clinical Research Institute|
|Tempe, Arizona, United States, 85284|
|United States, Colorado|
|Denver, Colorado, United States, 80230|
|United States, Minnesota|
|DaVita Clinical Research|
|Minneapolis, Minnesota, United States, 55404|
|Study Director:||David P Rosenbaum, PhD||Ardelyx, Inc.|