Phase 2 N=88 Randomized Quadruple-blind Treatment

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

End Stage Renal Disease · Chronic Kidney Disease Stage 5 · ESRD

Bottom Line

View on ClinicalTrials.gov: NCT01764854 ↗

Enrolled (actual)

Serious AEs

6.8%

Results posted

Aug 2020

Primary outcome: Primary: Change in Mean Weekly Interdialytic Weight Gain (IDWG) — -0.26; -0.23 kilograms — p=0.46

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AZD1722 (in-patient) (Drug); Placebo (in-patient) (Drug); AZD1722 (out-patient) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ardelyx
Primary completion: Oct 2013

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

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.

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

View full record on ClinicalTrials.gov →

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.