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

NCT01893242 | Withdrawn Phase 3

• 2 other identifiers: BC285042013-000088-10
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus Type 2, Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (1)

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

  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)

  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)

  Approximately 5 years

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

  Approximately 5 years

Study Arms (2)

Aleglitazar Arm

EXPERIMENTAL

Drug: Aleglitazar

Placebo Arm

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Aleglitazar DRUG

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

Aleglitazar Arm

Placebo DRUG

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

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Kidney Diseases; Bronchiolitis Obliterans Syndrome

Interventions

aleglitazar

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 8, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: November 2, 2016

Record last verified: 2016-11