Colchicine for Diabetic Nephropathy
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ClinicalTrials.gov Identifier: NCT01005121 |
Recruitment Status
: Unknown
Verified January 2013 by Prof.Avi Livneh, Sheba Medical Center.
Recruitment status was: Recruiting
First Posted
: October 30, 2009
Last Update Posted
: January 4, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Nephropathy | Drug: colchicine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 12 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Colchicine for Diabetic Nephropathy |
Study Start Date : | December 2009 |
Estimated Primary Completion Date : | December 2014 |
Estimated Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: colchicine
patients will receive 2 mg of colchicine daily
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Drug: colchicine
2mg, per-os, once daily for six months
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- 24 hr urine protein collection [ Time Frame: every 2 months ]

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005121
Contact: Shaye Kivity, MD | 03-5302436 | kivitys@gmail.com |
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 |
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 |
First Posted: | October 30, 2009 Key Record Dates |
Last Update Posted: | January 4, 2013 |
Last Verified: | January 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 |