Colchicine for Diabetic Nephropathy

Phase 2

• Conditions: Diabetic Nephropathy
• Interventions: Drug: colchicine

• Registration Number: NCT01005121
• Lead Sponsor: Prof.Avi Livneh

Brief Summary

Patients with diabetic nephropathy and proteinuria, despite maximal anti- hypertensive and anti-glucose treatment, will receive colchicine for six months, 2 mg a day, during which their 24 hour urine protein and renal function tests will be monitored. The investigators' hypothesis is that colchicine will diminish proteinuria and might also help slow down the development of end stage renal failure in the long run.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Study Start: 2009-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-03
• Last Update Posted: 2013-01-04
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Patients with DM aging 18+, able to sign an informed consent.
2. 24 hour protein collection between 0.5-6 mg during the last 6 months prior enrollment.
3. Hemoglobin A1c in the range of 6-9%, stable for the last year (0.5±)
4. Creatinine lower than 1.5 mg/dL.
5. Blood pressure lower than 150/90 mmHg on stable anti-hypertensive treatment for at least 3 months.
6. Treated with ACE & ARB, unless contraindicated

Exclusion criteria:

1. Malignancy or significant heart, lung or liver disease.
2. Any GI disease, IBD, malnutrition ( BMI under 18 )
3. Psychiatric disease
4. Any muscle disease, history of rhabdomyelysis, myopathy or myositis.
5. Any disease causing renal injury/proteinuria apart from DM
6. Any inflammatory or autoimmune disease
7. Any infection during the last month.
8. Use of potentially nephrotoxic drugs.
9. Woman in child bearing age that do not use at least one contraceptive device.
10. Pregnant or lactating woman.
11. Participation in another study during the last 3 months.
12. Alcohol or drug abusers
13. Anyone whom the investigators conclude are not appropriate
14. Any patient receiving steroids.
15. Any patient with Colchicine allergy, or treated with the drug during the last two weeks.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
colchicine	colchicine	patients will receive 2 mg of colchicine daily

Primary Outcome Measures

Name	Time	Method
24 hr urine protein collection	every 2 months

Trial Locations

Locations (1)

Sheba medical center, Tel hashomer; 🇮🇱 Ramat gan, Israel