Colchicine for Diabetic Nephropathy

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01005121

Enrollment

Registered

2009-10-30

Start date

2009-12-31

Completion date

2015-12-31

Last updated

2013-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Brief 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.

Interventions

DRUGcolchicine

2mg, per-os, once daily for six months

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
24 hr urine protein collection	every 2 months

Countries

Israel

Contacts

Primary ContactShaye Kivity, MD

kivitys@gmail.com03-5302436

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026