DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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


Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.


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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017