Status:
WITHDRAWN
A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus Type 2, Kidney Disease, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 di...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01893242
Start Date
December 1 2013
End Date
January 1 2019
Last Update
November 2 2016
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