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A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study)

Primary Purpose

Diabetes Mellitus Type 2, Kidney Disease, Chronic

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Aleglitazar

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2, Kidney Disease, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aleglitazar Arm

Placebo Arm

Arm Description

Outcomes

Primary Outcome Measures

Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death

Secondary Outcome Measures

Time to the first occurrence of any component of major adverse cardiovascular event composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)

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 to the first occurrence of any component of composite outcome of end-stage renal disease and all-cause mortality

Full Information

NCT ID

NCT01893242

First Posted

July 2, 2013

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01893242

Brief Title

A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal 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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Withdrawn

Study Start Date

December 2013 (undefined)

Primary Completion Date

January 2019 (Anticipated)

Study Completion Date

January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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. Patients will be randomized to receive oral daily doses of aleglitazar or matching placebo. The anticipated time on study treatment is approximately 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type 2, Kidney Disease, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aleglitazar Arm

Arm Type

Experimental

Arm Title

Placebo Arm

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Aleglitazar

Intervention Description

Aleglitazar 150 mcg oral doses, once a day for approximately 3 years

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo to aleglitazar, once a day for approximately 3 years

Primary Outcome Measure Information:

Title

Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death

Time Frame

Approximately 5 years

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study)

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