Colchicine for Diabetic Nephropathy
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2013 by Sheba Medical Center
Sponsor:
Prof.Avi Livneh
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
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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:
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:
- Patients with DM aging 18+, able to sign an informed consent.
- 24 hour protein collection between 0.5-6 mg during the last 6 months prior enrollment.
- Hemoglobin A1c in the range of 6-9%, stable for the last year (0.5±)
- Creatinine lower than 1.5 mg/dL.
- Blood pressure lower than 150/90 mmHg on stable anti-hypertensive treatment for at least 3 months.
- Treated with ACE & ARB, unless contraindicated
Exclusion criteria:
- Malignancy or significant heart, lung or liver disease.
- Any GI disease, IBD, malnutrition ( BMI under 18 )
- Psychiatric disease
- Any muscle disease, history of rhabdomyelysis, myopathy or myositis.
- Any disease causing renal injury/proteinuria apart from DM
- Any inflammatory or autoimmune disease
- Any infection during the last month.
- Use of potentially nephrotoxic drugs.
- Woman in child bearing age that do not use at least one contraceptive device.
- Pregnant or lactating woman.
- Participation in another study during the last 3 months.
- Alcohol or drug abusers
- Anyone whom the investigators conclude are not appropriate
- Any patient receiving steroids.
- Any patient with Colchicine allergy, or treated with the drug during the last two weeks.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005121
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 Diabetes Complications Diabetes Mellitus Endocrine System Diseases Urologic Diseases Colchicine Antimitotic Agents |
Antineoplastic Agents Antirheumatic Agents Gout Suppressants Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Tubulin Modulators |
ClinicalTrials.gov processed this record on March 02, 2015