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

NCT01764854 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2020-08-10

Study results available
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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.

Conditions

Interventions

DRUG

AZD1722 (in-patient)

doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting

DRUG

Placebo (in-patient)

Placebo, size and color matched to experimental drug administered in a CPU

DRUG

AZD1722 (out-patient)

doses between 5 and 45 mg BID

DRUG

Placebo

Placebo, size and color matched to experimental drug

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Ardelyx

    lead INDUSTRY

Principal Investigators

  • David P Rosenbaum, PhD · Ardelyx, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01764854 on ClinicalTrials.gov