Colchicine for Diabetic Nephropathy

Diabetic Nephropathy Clinical Trial

Official title:

Colchicine for Diabetic Nephropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01005121
• Other study ID #: SHEBA-09-7369-AL-CTIL
• Status: Recruiting
• Phase: Phase 2
• First received: October 29, 2009
• Last updated: January 3, 2013
• Start date: December 2009
• Est. completion date: December 2015

Study information

• Verified date: January 2013
• Source: Sheba Medical Center
• Contact: Shaye Kivity, MD
• Phone: 03-5302436
• Email: kivitys[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• colchicine
2mg, per-os, once daily for six months

Locations

Country	Name	City	State
Israel	Sheba medical center, Tel hashomer	Ramat gan

Sponsors (1)

Lead Sponsor	Collaborator
Prof.Avi Livneh

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hr urine protein collection		every 2 months	No