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Tracking Information | |||||
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First Received Date ICMJE | October 29, 2009 | ||||
Last Updated Date | October 29, 2009 | ||||
Start Date ICMJE | December 2009 | ||||
Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
24 hr urine protein collection [ Time Frame: every 2 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Colchicine for Diabetic Nephropathy | ||||
Official Title ICMJE | Colchicine for 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. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Diabetic Nephropathy | ||||
Intervention ICMJE | Drug: colchicine
2mg, per-os, once daily for six months |
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Study Arms | Experimental: colchicine
patients will receive 2 mg of colchicine daily
Intervention: Drug: colchicine |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE | 12 | ||||
Completion Date | |||||
Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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Gender | Both | ||||
Ages | 18 Years to 90 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Israel | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01005121 | ||||
Other Study ID Numbers ICMJE | SHEBA-09-7369-AL-CTIL | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Prof Avi Livneh, Head of Internal medicine department F, Sheba medical center | ||||
Study Sponsor ICMJE | Sheba Medical Center | ||||
Collaborators ICMJE | |||||
Investigators ICMJE | |||||
Information Provided By | Sheba Medical Center | ||||
Verification Date | October 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |