End Stage Renal Disease Clinical Trial
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
Verified date | August 2020 |
Source | Ardelyx |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Males or females aged 18 to 80 years, inclusive; - Body mass index between 18 and 45 kg/m2, inclusive; - Ambulatory (= 6 months) maintenance hemodialysis; - Stable dialysis treatment regimen 3x/week for = 2 months prior to screening visit. Exclusion Criteria: - Currently taking diuretic medication; - Has a urine production of = 200 ml/day (based on a 24-hour measurement starting on Day -1 and completed prior to randomization); - Predialysis systolic BP >200 mmHg or diastolic BP >110 mmHg on two successive occasions during the 2-week run-in period; - Predialysis SBP < 110 mmHg on two successive occasions during the 2-week run-in period |
Country | Name | City | State |
---|---|---|---|
United States | Denver Nephrology | Denver | Colorado |
United States | DaVita Clinical Research | Minneapolis | Minnesota |
United States | Southwest Clinical Research Institute | Tempe | Arizona |
Lead Sponsor | Collaborator |
---|---|
Ardelyx | AstraZeneca |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Mean Weekly Interdialytic Weight Gain (IDWG) | Patients are weighed pre dialysis prior to their first dialysis of the week. This measure looks at the change in pre-dialysis weight over time | Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment) | |
Secondary | Stool Sodium Content | The amount of sodium in a days worth of stool output | Days 1 through 7 |
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