Colchicine for Diabetic Nephropathy
Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Nephropathy
Intervention: colchicine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Prof.Avi Livneh Overall contact: Shaye Kivity, MD, Phone: 03-5302436, Email: kivitys@gmail.com
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.
Clinical Details
Official title: Colchicine for Diabetic Nephropathy
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 24 hr urine protein collection
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Shaye Kivity, MD, Phone: 03-5302436, Email: kivitys@gmail.com
Sheba medical center, Tel hashomer, Ramat gan 52621, Israel; Recruiting Shaye Kivity, MD, Phone: 03-5302436, Email: kivitys@gmail.com Shaye Kivity, MD, Sub-Investigator
Additional Information
Starting date: December 2009
Last updated: January 3, 2013
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