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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01764854
Recruitment Status : Completed
First Posted : January 10, 2013
Last Update Posted : February 27, 2014
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Chronic Kidney Disease Stage 5 ESRD Drug: AZD1722 Phase 2

Detailed Description:

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacodynamics of the study drug in male and female patients with end-stage renal disease on hemodialysis. The study consists of a 2 week treatment-free run-in period where entry criteria are verified, a 4-week treatment period, of which the first week of treatment will be performed as an in-patient study in a clinical pharmacology unit (CPU) and the remaining three weeks of treatment will performed as an out-patient study, and a 2-week treatment-free follow-up period.

Safety assessments will be performed at regular intervals and will include clinical and vital signs, clinical laboratory evaluations, ECGs, and AE monitoring. Pharmacodynamic assessments will include, but are not limited to, interdialytic weight gain (IDWG), blood pressure, and stool sodium excretion. Pharmacokinetic assessments will include blood sampling for measurement of study drug plasma concentrations.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: AZD1722 Drug: AZD1722
doses between 5 and 90 mg may be administered based on tolerability
Other Name: RDX5791

Placebo Comparator: Placebo

Primary Outcome Measures :
  1. Reduction in mean weekly interdialytic weight gain (IDWG) [ Time Frame: Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment) ]

Secondary Outcome Measures :
  1. Stool sodium content [ Time Frame: Days 1 through 7 ]
  2. Reduction in mean weekly IDWG [ Time Frame: Run-in period (Weeks -2 and -1) versus weeks 1, 2, and 3 and follow-up, weeks 5 and 6 ]
  3. Plasma concentrations of study drug [ Time Frame: Study Days 1, 3, 5, 7 and 29 ]
  4. Evaluate the safety and tolerability of 4 weeks of treatment [ Time Frame: Weeks 1, 2, 3, and 4 ]
    AEs, SAEs, and safety laboratory evaluations.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01764854

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United States, Arizona
Southwest Clinical Research Institute
Tempe, Arizona, United States, 85284
United States, Colorado
Denver Nephrology
Denver, Colorado, United States, 80230
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
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Study Director: David P Rosenbaum, PhD Ardelyx, Inc.

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Responsible Party: Ardelyx Identifier: NCT01764854     History of Changes
Other Study ID Numbers: D5611C00001
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: February 27, 2014
Last Verified: February 2014
Keywords provided by Ardelyx:
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency