search
Back to results

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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AZD1722 (in-patient)
Placebo (in-patient)
AZD1722 (out-patient)
Placebo
Sponsored by
Ardelyx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Hemodialysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest Clinical Research Institute
  • Denver Nephrology
  • DaVita Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

AZD1722- in patient

Placebo- in patient

AZD1722 out-patient

Placebo out-patient

Arm Description

Tenapanor administered in a clinical pharmacology unit

Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit

Tenapanor

Placebo

Outcomes

Primary Outcome Measures

Change in Mean Weekly Interdialytic Weight Gain (IDWG)
Patients are weighed pre dialysis prior to their first dialysis of the week. This measure looks at the change in pre-dialysis weight over time

Secondary Outcome Measures

Stool Sodium Content
The amount of sodium in a days worth of stool output

Full Information

First Posted
January 4, 2013
Last Updated
August 6, 2020
Sponsor
Ardelyx
Collaborators
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT01764854
Brief Title
Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis
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 Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardelyx
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Chronic Kidney Disease Stage 5, ESRD
Keywords
Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZD1722- in patient
Arm Type
Experimental
Arm Description
Tenapanor administered in a clinical pharmacology unit
Arm Title
Placebo- in patient
Arm Type
Placebo Comparator
Arm Description
Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit
Arm Title
AZD1722 out-patient
Arm Type
Experimental
Arm Description
Tenapanor
Arm Title
Placebo out-patient
Arm Type
Experimental
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
AZD1722 (in-patient)
Other Intervention Name(s)
RDX5791, Tenapanor
Intervention Description
doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting
Intervention Type
Drug
Intervention Name(s)
Placebo (in-patient)
Intervention Description
Placebo, size and color matched to experimental drug administered in a CPU
Intervention Type
Drug
Intervention Name(s)
AZD1722 (out-patient)
Other Intervention Name(s)
Tenapanor
Intervention Description
doses between 5 and 45 mg BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, size and color matched to experimental drug
Primary Outcome Measure Information:
Title
Change in Mean Weekly Interdialytic Weight Gain (IDWG)
Description
Patients are weighed pre dialysis prior to their first dialysis of the week. This measure looks at the change in pre-dialysis weight over time
Time Frame
Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment)
Secondary Outcome Measure Information:
Title
Stool Sodium Content
Description
The amount of sodium in a days worth of stool output
Time Frame
Days 1 through 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P Rosenbaum, PhD
Organizational Affiliation
Ardelyx, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Southwest Clinical Research Institute
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Denver Nephrology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
DaVita Clinical Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs