/A

• Conditions: Patients with Diabetic Kidney Disease due to Type 1 or Type 2 Diabetes; MedDRA version: 15.0Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2010-020404-29-CZ
• Lead Sponsor: Eli Lilly and Company Limited, Indianapolis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-02
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Men and women not of childbearing potential =25 years of age with type 1 or type 2 diabetes mellitus and either an SCr of 1.3 to 3.3 mg/dL (115 to 291 µmol/L) in women and 1.5 to 3.5 mg/dL (132 to 309 µmol/L) in men, or an estimated glomerular filtration rate (eGFR) of 20 to 60 mL/min/1.73m2, and a 24-hour urine PCR of =800 mg/g (=91 mg/mmol), despite equilibration for =2 months on an appropriate dose of either ACEi or ARB therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Chronic kidney disease (CKD) from causes other than presumed DKD, uncontrolled hypertension, unstable cardiovascular disease, cancer or predisposing conditions, autoimmune disease, chronic inflammatory disease, hepatitis B or C infection, cirrhosis or significant liver disease, systemic immunosuppression therapy, and recent gastrointestinal bleeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified