Chronic Kidney DiseasePhase 2NCT01847092

A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria

A Phase 2 study testing AZD1722 in people with Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Ardelyx at 1 site 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 albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Chronic Kidney Disease, Type 2 Diabetes Mellitus
What is being tested?: AZD1722
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 154 participants
Where: 1 siteUnited States
Study dates: May 2013to Apr 2015
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.
Type 2 diabetes mellitus and receiving ≥1 glucose lowering medication for at least 3 months prior to randomization
Stage 3 CKD
MSSBP ≥130 mmHg
Urinary albumin: mean UACR ≥ 200 mg/g

Who cannot join

Urinary albumin: UACR > 3500 mg/g
History of a renal transplant
MSSBP >180 mmHg or a MSDBP of >120 mmHg on two occasions during screening or run-in periods
History of inflammatory bowel disease or diarrhea predominant irritable bowel syndrome

Trial locations and contacts

1 site in 1 country.

United States1 site

Creekside Endocrine Associates PC
Denver, Colorado, 80209

Other trials in United States

About this study

Official title: An Exploratory Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Design Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD1722 in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria

The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.

Conditions: Chronic Kidney Disease, Type 2 Diabetes Mellitus
Being tested: AZD1722, Placebo
Keywords: albuminuria
Medical subject headings: Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Albuminuria

What participants receive

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

AZD1722Drug
PlaceboDrug
Placebo for AZD1722

Study groups in NCT01847092
Study group	Role	What they receive
AZD1722	Active comparator	AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks Receives: Drug: AZD1722
Placebo	Placebo comparator	Placebo capsule BID PO for 12 Weeks Receives: Drug: Placebo

What is being measured

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

Changes in Urine Albumin to Creatinine Ratio (UACR)
The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment
Measured: Week 12

Secondary outcomes (1)

Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint
Measured: 12 weeks

Timeline

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

May 2013Apr 2015

First posted6 May 2013 (estimated)
Study startMay 2013
Primary completionMar 2015
Study completionApr 2015

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 Chronic Kidney 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: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01847092
Sponsor's protocol ID: D5610C00001
Status last verified: May 2020
First submitted: 2 May 2013
Last updated: 27 May 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?

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All Chronic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Design Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD1722 in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
ClinicalTrials.gov ID: NCT01847092
Acronym / sponsor ID: D5610C00001
Conditions: Chronic Kidney Disease, Type 2 Diabetes Mellitus
Keywords: albuminuria
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: ArdelyxIndustry (pharma, biotech, devices)
Collaborators: AstraZeneca
Study start: May 2013
Primary completion: Mar 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 6 May 2013 (estimated)
Results: Posted 27 May 2020

Clinical summary

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

The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
AZD1722	Active comparator	Drug: AZD1722AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
Placebo	Placebo comparator	Drug: PlaceboPlacebo capsule BID PO for 12 Weeks

Who may qualify

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

Key inclusion criteria (6 listed)

Males or females aged 18 to 80 years, inclusive.
Body mass index between 18 and 45 kg/m2, inclusive.
Type 2 diabetes mellitus and receiving ≥1 glucose lowering medication for at least 3 months prior to randomization
Stage 3 CKD
MSSBP ≥130 mmHg

Key exclusion criteria (4 listed)

Urinary albumin: UACR > 3500 mg/g
History of a renal transplant
MSSBP >180 mmHg or a MSDBP of >120 mmHg on two occasions during screening or run-in periods
History of inflammatory bowel disease or diarrhea predominant irritable bowel syndrome

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	Drug	AZD1722
PlaceboPlacebo for AZD1722	Drug	Placebo

Primary outcome

Changes in Urine Albumin to Creatinine Ratio (UACR)
Time frame: Week 12
The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment

1 secondary outcome

Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint
Time frame: 12 weeks

Results and safety

Results posted to the registry on 27 May 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	77	51
Placebo	77	66

Primary outcome: Changes in Urine Albumin to Creatinine Ratio (UACR)

Time frame: Week 12. Mean (Standard Deviation). Unit: mg/g

Measure	AZD1722 n = 77	Placebo n = 77
Value	-64.6 (898.4)	104.8 (668.0)

AZD1722 vs Placebo: p = 0.279, Mixed Models Analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD1722	3 of 77 (3.9%)	45 of 77 (58.4%)	0 of 77
Placebo	2 of 77 (2.6%)	4 of 77 (5.2%)	0 of 77

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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End Stage Renal Disease
RecruitingPhase 3
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Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site 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 people with Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Ardelyx at 1 site 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 6 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 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 27 May 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?

Changes in Urine Albumin to Creatinine Ratio (UACR) (time frame: Week 12). 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 NCT01847092.

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 27 May 2020.