Colchicine for Diabetic Nephropathy

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Nephropathy
• Intervention / Treatment: Drug: colchicine

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shaye Kivity, MD; Phone Number: 03-5302436; Email: kivitys@gmail.com

Study Locations

• Israel
  • Ramat gan, Israel, 52621
    • Recruiting
    • Sheba Medical Center, Tel Hashomer
    • Contact: Shaye Kivity, MD; Phone Number: 03-5302436; Email: kivitys@gmail.com
    • Sub-Investigator: Shaye Kivity, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: colchicine; patients will receive 2 mg of colchicine daily	Drug: colchicine; 2mg, per-os, once daily for six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
24 hr urine protein collection	every 2 months

Collaborators and Investigators

• Sponsor: Prof.Avi Livneh

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: October 29, 2009
• First Submitted That Met QC Criteria: October 29, 2009
• First Posted (Estimate): October 30, 2009

Study Record Updates

• Last Update Posted (Estimate): January 4, 2013
• Last Update Submitted That Met QC Criteria: January 3, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Kidney Diseases; Diabetic Nephropathies; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: SHEBA-09-7369-AL-CTIL