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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ardelyx
• Collaborator: AstraZeneca

Criteria

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