A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study) (NCT01893242) | Clinical Trial Compass
WithdrawnPhase 3
A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study)
0Started 2013-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 screeni…
What they're measuring
1
Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death