NCT01764854

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

August 10, 2020

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

9 months

First QC Date

January 4, 2013

Results QC Date

May 21, 2020

Last Update Submit

August 6, 2020

Conditions

End Stage Renal DiseaseChronic Kidney Disease Stage 5ESRD

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (1)

  • 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

    Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment)

Secondary Outcomes (1)

  • Stool Sodium Content

    Days 1 through 7

Study Arms (4)

AZD1722- in patient

EXPERIMENTAL

Tenapanor administered in a clinical pharmacology unit

Drug: AZD1722 (in-patient)

Placebo- in patient

PLACEBO COMPARATOR

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

Drug: Placebo (in-patient)

AZD1722 out-patient

EXPERIMENTAL

Tenapanor

Drug: AZD1722 (out-patient)

Placebo out-patient

EXPERIMENTAL

Placebo

Drug: Placebo

Interventions

AZD1722 (in-patient)DRUG

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

Also known as: RDX5791, Tenapanor
AZD1722- in patient
Placebo (in-patient)DRUG

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

Placebo- in patient
AZD1722 (out-patient)DRUG

doses between 5 and 45 mg BID

Also known as: Tenapanor
AZD1722 out-patient
PlaceboDRUG

Placebo, size and color matched to experimental drug

Placebo out-patient

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Southwest Clinical Research Institute

Tempe, Arizona, 85284, United States

Location

Denver Nephrology

Denver, Colorado, 80230, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency, Chronic

Interventions

tenapanor

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Chief Development Officer
Organization
Ardelyx, Inc.
drosenbaum@ardelyx.com
617 513-4929

Study Officials

  • David P Rosenbaum, PhD

    Ardelyx, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 10, 2013

Study Start

January 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

August 10, 2020

Results First Posted

August 10, 2020

Record last verified: 2020-08

Locations

US(3)