End Stage Renal DiseasePhase 2NCT01764854

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

A Phase 2 study testing AZD1722 (in-patient) and AZD1722 (out-patient) in people with End Stage Renal Disease and Chronic Kidney Disease Stage 5, run by Ardelyx at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: End Stage Renal Disease, Chronic Kidney Disease Stage 5, ESRD
What is being tested?: AZD1722 (in-patient) and AZD1722 (out-patient)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 88 participants
Where: 3 sitesUnited States
Study dates: Jan 2013to Oct 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Denver Nephrology
Denver, Colorado, 80230
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Southwest Clinical Research Institute
Tempe, Arizona, 85284

Other trials in United States

About this study

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

Read the 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.

Conditions: End Stage Renal Disease, Chronic Kidney Disease Stage 5, ESRD
Being tested: AZD1722 (in-patient), Placebo (in-patient), AZD1722 (out-patient), Placebo
Keywords: Hemodialysis
Medical subject headings: Kidney Failure, Chronic, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD1722 (in-patient)Drug
Also called RDX5791, Tenapanor
doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting
Placebo (in-patient)Drug
Placebo, size and color matched to experimental drug administered in a CPU
AZD1722 (out-patient)Drug
Also called Tenapanor
doses between 5 and 45 mg BID
PlaceboDrug
Placebo, size and color matched to experimental drug

Study groups in NCT01764854
Study group	Role	What they receive
AZD1722- in patient	Experimental	Tenapanor administered in a clinical pharmacology unit Receives: Drug: AZD1722 (in-patient)
Placebo- in patient	Placebo comparator	Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit Receives: Drug: Placebo (in-patient)
AZD1722 out-patient	Experimental	Tenapanor Receives: Drug: AZD1722 (out-patient)
Placebo out-patient	Experimental	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

Stool Sodium Content
The amount of sodium in a days worth of stool output
Measured: Days 1 through 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Oct 2013

First posted10 Jan 2013 (estimated)
Study startJan 2013
Primary completionOct 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01764854
Sponsor's protocol ID: D5611C00001
Status last verified: Aug 2020
First submitted: 4 Jan 2013
Last updated: 10 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01764854
Acronym / sponsor ID: D5611C00001
Conditions: End Stage Renal Disease, Chronic Kidney Disease Stage 5, ESRD
Keywords: Hemodialysis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: ArdelyxIndustry (pharma, biotech, devices)
Collaborators: AstraZeneca
Study start: Jan 2013
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 10 Jan 2013 (estimated)
Results: Posted 10 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
AZD1722- in patient	Experimental	Drug: AZD1722 (in-patient)Tenapanor administered in a clinical pharmacology unit
Placebo- in patient	Placebo comparator	Drug: Placebo (in-patient)Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit
AZD1722 out-patient	Experimental	Drug: AZD1722 (out-patient)Tenapanor
Placebo out-patient	Experimental	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD1722 (in-patient)Also: RDX5791, Tenapanordoses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting	Drug	AZD1722- in patient
Placebo (in-patient)Placebo, size and color matched to experimental drug administered in a CPU	Drug	Placebo- in patient
AZD1722 (out-patient)Also: Tenapanordoses between 5 and 45 mg BID	Drug	AZD1722 out-patient
PlaceboPlacebo, size and color matched to experimental drug	Drug	Placebo out-patient

Primary outcome

Change in Mean Weekly Interdialytic Weight Gain (IDWG)
Time frame: Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment)
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

1 secondary outcome

Stool Sodium Content
Time frame: Days 1 through 7

Results and safety

Results posted to the registry on 10 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD1722- in Patient	8	8
Placebo- in Patient	8	8
AZD1722 Out-patient	37	31
Placebo Out-patient	35	33

Primary outcome: Change in Mean Weekly Interdialytic Weight Gain (IDWG)

Time frame: Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment). Mean (Standard Deviation). Unit: kilograms

Measure	AZD1722 Out-patient n = 37	Placebo Out-patient n = 35
Value	-0.26 (0.939)	-0.23 (0.871)

AZD1722 Out-patient vs Placebo Out-patient: p = 0.46, ANCOVA

Population analysed: The out-patient arms were the only groups that were pre-specified to be included in this analysis since the in-patient arms were only treated for one week.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: one month. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD1722- in Patient	0 of 8 (0%)	6 of 8 (75%)	0 of 8
Placebo- in Patient	3 of 8 (37.5%)	2 of 8 (25%)	0 of 8
AZD1722 Out-patient	2 of 37 (5.4%)	3 of 37 (8.1%)	0 of 37
Placebo Out-patient	1 of 35 (2.9%)	21 of 35 (60%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David P Rosenbaum, PhD study director

Ardelyx, Inc.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD1722 (in-patient) and AZD1722 (out-patient) in people with End Stage Renal Disease and Chronic Kidney Disease Stage 5, run by Ardelyx at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean Weekly Interdialytic Weight Gain (IDWG) (time frame: Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01764854.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.