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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Ardelyx
ClinicalTrials.gov Identifier:
NCT01764854
First received: January 4, 2013
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
End Stage Renal Disease
Chronic Kidney Disease Stage 5
ESRD
Drug: AZD1722
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Ardelyx:

Primary Outcome Measures:
  • Reduction in mean weekly interdialytic weight gain (IDWG) [ Time Frame: Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stool sodium content [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Plasma concentrations of study drug [ Time Frame: Study Days 1, 3, 5, 7 and 29 ] [ Designated as safety issue: Yes ]
  • Evaluate the safety and tolerability of 4 weeks of treatment [ Time Frame: Weeks 1, 2, 3, and 4 ] [ Designated as safety issue: Yes ]
    AEs, SAEs, and safety laboratory evaluations.


Enrollment: 88
Study Start Date: January 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD1722 Drug: AZD1722
doses between 5 and 90 mg may be administered based on tolerability
Other Name: RDX5791
Placebo Comparator: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764854

Locations
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
Ardelyx
AstraZeneca
Investigators
Study Director: David P Rosenbaum, PhD Ardelyx, Inc.
  More Information

No publications provided

Responsible Party: Ardelyx
ClinicalTrials.gov Identifier: NCT01764854     History of Changes
Other Study ID Numbers: D5611C00001
Study First Received: January 4, 2013
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ardelyx:
Hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 18, 2014