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Colchicine for Diabetic Nephropathy
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Prof.Avi Livneh, Sheba Medical Center.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
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: | 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 Prof.Avi Livneh, Sheba Medical Center:
Primary Outcome Measures:
- 24 hr urine protein collection [ Time Frame: every 2 months ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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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
| 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 |
Additional relevant MeSH terms:
|
Kidney Diseases Diabetic Nephropathies Urologic Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Colchicine |
Gout Suppressants Antirheumatic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 23, 2017