Colchicine for Diabetic Nephropathy Trial

• Status: Unknown status
• Trial end date: 2019-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Forty patients with diabetic nephropathy will be treated with colchicine up to 2 mg, or placebo, for 18 months. A follow up will be performed after 12 additional months. The primary outcome will be a significant reduction or stabilization of proteinuria during the 18 month treatment period.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Collaborator: D-Cure, Israel
• Treatments: Colchicine

Criteria

Inclusion Criteria:

1. Patients with diabetes mellitus , age>18 years old, able to sign an informed consent.

2. Hemoglobin A1c in the range of 6-9%, stable for last year (0.5±)

3. Blood creatinine lower than 2 mg/dL.

4. Blood pressure lower than 140/90 mmHg on stable anti-hypertensive treatment for at least 3 months.

5. Treated with ACE or angiotensin II receptor blocker , unless contraindicated

Exclusion Criteria:

1. Malignancy or significant heart, lung or liver disease.

2. Any GI disease, inflammatory bowel disease , malnutrition ( BMI under 18 )

3. Psychiatric disease

4. Any muscle disease, history of rhabdomyolysis , myopathy or myositis.

5. Any disease causing renal injury/proteinuria apart from diabetes mellitus

6. Any inflammatory or autoimmune disease

7. Any infection during the last month.