Phase 2
Completed N=88
Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis
Source: ClinicalTrials.gov NCT01764854 ↗Enrolled (actual)
88
Serious AEs
6.8%
Results posted
Aug 2020
Primary outcomePrimary: Change in Mean Weekly Interdialytic Weight Gain (IDWG) — -0.26; -0.23 kilograms — p=0.46
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Weekly Interdialytic Weight Gain (IDWG) |
-0.26; -0.23 | 0.46 |
| SECONDARY Stool Sodium Content |
36.62; 2.82 | <0.0001 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01764854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.