Diabetes Mellitus Type 2, Kidney Disease, ChronicPhase 3NCT01893242
A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study)
A Phase 3 study testing Aleglitazar in people with Diabetes Mellitus Type 2, Kidney Disease, Chronic, run by Hoffmann-La Roche.
Trial summary
This randomized, double-blind, placebo-controlled study will evaluate the potential of aleglitazar to reduce the risk of end stage renal disease and cardiovascular mortality in patients with type 2 diabetes mellitus and chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, Kidney Disease, Chronic
- What is being tested?
- Aleglitazar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Jan 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients >= 18 years of age at screening
- Diagnosis of diabetes mellitus Type 2
- Glycosylated hemoglobin A1C (HbA1C) < 10% at screening
- Estimated glomerular filtration rate (eGFR) >=30 and < 60 mL/min/1.73 m2
- Urinary albumin-to-creatinine ratio (UACR) >=500 and < 5000 mg/g
- Treatment with either angiotensin converting enzyme inhibitor or angiotensin II receptor blocker for at least three months prior to screening
- Women of child-bearing potential using a highly effective birth control method must be willing to use the same method of contraception during the entire course of the study
Who cannot join
- Treatment with a PPARgamma agonist and/or PPARalpha agonist in the last 12 weeks screening
- Prior intolerance to a TDZ or fibrate
- Previous participation in a trial with aleglitazar
- Diagnosis or history of other types of diabetes
- Diagnosis or history of acute metabolic diabetic complications within the past 6 months
- Known primary glomerulonephritis, secondary glomerulonephritis other than diabetic nephropathy or polycystic kidney disease
Show all 15Show fewer
- Diagnosed acute kidney injury or dialysis within 12 weeks prior to screening
- Poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg at baseline)
- Known secondary hypertension due to renal artery stenosis, primary aldosteronism, or pheochromocytoma
- History of myocardial infarction or stroke in the past 12 weeks prior to screening
- Symptomatic congestive heart failure NYHA class II-IV at baseline or heart failure leading to hospitalization within the 12 months prior to screening
- Diagnosed and/or treated malignancy (except for treated cases of basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
- Inadequate liver and hematological function
- Chronic treatment with immunosuppressive therapy
- Women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective birth control methods
About this study
Official title: A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE THE RISK OF END STAGE RENAL DISEASE AND CARDIOVASCULAR MORTALITY IN PATIENTS WITH TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE (ALERENAL STUDY)
This randomized, double-blind, placebo-controlled study will evaluate the potential of aleglitazar to reduce the risk of end stage renal disease and cardiovascular mortality in patients with type 2 diabetes mellitus and chronic kidney disease. Patients will be randomized to receive oral daily doses of aleglitazar or matching placebo. The anticipated time on study treatment is approximately 3 years.
- Being tested
- Aleglitazar, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Kidney Diseases, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AleglitazarDrug
Aleglitazar 150 mcg oral doses, once a day for approximately 3 years
PlaceboDrug
Matching placebo to aleglitazar, once a day for approximately 3 years
| Study group | Role | What they receive |
|---|---|---|
| Aleglitazar Arm | Experimental | Not described Receives: Drug: Aleglitazar |
| Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death
Measured: Approximately 5 years
Secondary outcomes (3)
Time to the first occurrence of any component of major adverse cardiovascular event composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
Measured: Approximately 5 years
Time to the first occurrence of any component of macrovascular composite (CV death, non fatal myocardial infarction, hospitalization for unstable angina, non fatal stroke)
Measured: Approximately 5 years
Time to the first occurrence of any component of composite outcome of end-stage renal disease and all-cause mortality
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2, Kidney Disease, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893242
- Sponsor's protocol ID
- BC28504
- Other IDs
- 2013-000088-10
- Status last verified
- Nov 2016
- First submitted
- 2 Jul 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE THE RISK OF END STAGE RENAL DISEASE AND CARDIOVASCULAR MORTALITY IN PATIENTS WITH TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE (ALERENAL STUDY)
- ClinicalTrials.gov ID
- NCT01893242
- Acronym / sponsor ID
- BC28504
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 8 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo-controlled study will evaluate the potential of aleglitazar to reduce the risk of end stage renal disease and cardiovascular mortality in patients with type 2 diabetes mellitus and chronic kidney disease. Patients will be randomized to receive oral daily doses of aleglitazar or matching placebo. The anticipated time on study treatment is approximately 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aleglitazar Arm | Experimental | Drug: Aleglitazar |
| Placebo Arm | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients >= 18 years of age at screening
- Diagnosis of diabetes mellitus Type 2
- Glycosylated hemoglobin A1C (HbA1C) < 10% at screening
- Estimated glomerular filtration rate (eGFR) >=30 and < 60 mL/min/1.73 m2
- Urinary albumin-to-creatinine ratio (UACR) >=500 and < 5000 mg/g
Key exclusion criteria (15 listed)
- Treatment with a PPARgamma agonist and/or PPARalpha agonist in the last 12 weeks screening
- Prior intolerance to a TDZ or fibrate
- Previous participation in a trial with aleglitazar
- Diagnosis or history of other types of diabetes
- Diagnosis or history of acute metabolic diabetic complications within the past 6 months
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 |
|---|---|---|
| AleglitazarAleglitazar 150 mcg oral doses, once a day for approximately 3 years | Drug | Aleglitazar Arm |
| PlaceboMatching placebo to aleglitazar, once a day for approximately 3 years | Drug | Placebo Arm |
Primary outcome
Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death
Time frame: Approximately 5 years
3 secondary outcomes
Time to the first occurrence of any component of major adverse cardiovascular event composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
Time frame: Approximately 5 years
Time to the first occurrence of any component of macrovascular composite (CV death, non fatal myocardial infarction, hospitalization for unstable angina, non fatal stroke)
Time frame: Approximately 5 years
Time to the first occurrence of any component of composite outcome of end-stage renal disease and all-cause mortality
Time frame: Approximately 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aleglitazar in people with Diabetes Mellitus Type 2, Kidney Disease, Chronic, run by Hoffmann-La Roche.
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 7 inclusion and 15 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: withdrawn, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death (time frame: Approximately 5 years). 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 2 Nov 2016.