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Colchicine for Diabetic Nephropathy

This study is currently recruiting participants.
Verified January 2013 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Prof.Avi Livneh, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01005121
First received: October 29, 2009
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetic Nephropathy
 Drug: colchicine
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Colchicine for Diabetic Nephropathy

Resource links provided by NLM:

Drug Information available for: Colchicine
U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 24 hr urine protein collection [ Time Frame: every 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: December 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: colchicine
patients will receive 2 mg of colchicine daily
 Drug: colchicine
2mg, per-os, once daily for six months

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005121

Contacts
Contact: Shaye Kivity, MD 03-5302436 kivitys@gmail.com

Locations
Israel
Sheba medical center, Tel hashomer Recruiting
Ramat gan, Israel, 52621
Contact: Shaye Kivity, MD     03-5302436     kivitys@gmail.com    
Sub-Investigator: Shaye Kivity, MD            
Sponsors and Collaborators
Prof.Avi Livneh
  More Information

No publications provided

Responsible Party: Prof.Avi Livneh, Dept Head, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01005121     History of Changes
Other Study ID Numbers: SHEBA-09-7369-AL-CTIL
Study First Received: October 29, 2009
Last Updated: January 3, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Colchicine
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 17, 2013