Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis

Completed · Phase 2 · Has a placebo group

Conditions studied: End Stage Renal Disease, Chronic Kidney Disease Stage 5, ESRD

In brief

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.

Key facts

Study ID

NCT01764854

Run by

Ardelyx

People needed

88

Starts

2013-01-01

Expected to finish

2013-10-01

Last updated by the study team

2020-08-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Southwest Clinical Research Institute — Tempe, Arizona, United States
• Denver Nephrology — Denver, Colorado, United States
• DaVita Clinical Research — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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