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.
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Ardelyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
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
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
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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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?
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.