Colchicine for Diabetic Nephropathy

Prof.Avi Livneh

Status and phase: Unknown; Phase 2

Conditions: Diabetic Nephropathy

Treatments: Drug: colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT01005121

SHEBA-09-7369-AL-CTIL

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

colchicine

Experimental group

Description:

patients will receive 2 mg of colchicine daily

Treatment:

Drug: colchicine