Trial record 16 of 60 for:
Open Studies | "Diabetic Nephropathies"
Colchicine for Diabetic Nephropathy
This study is currently recruiting participants.
Verified January 2013 by Sheba Medical Center
Information provided by (Responsible Party):
Prof.Avi Livneh, Sheba Medical Center
First received: October 29, 2009
Last updated: January 3, 2013
Last verified: January 2013
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.
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Colchicine for Diabetic Nephropathy
Primary Outcome Measures:
- 24 hr urine protein collection [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
patients will receive 2 mg of colchicine daily
2mg, per-os, once daily for six months
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005121
|Sheba medical center, Tel hashomer
|Ramat gan, Israel, 52621 |
|Contact: Shaye Kivity, MD 03-5302436 firstname.lastname@example.org |
|Sub-Investigator: Shaye Kivity, MD |
No publications provided
||Prof.Avi Livneh, Dept Head, Sheba Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 29, 2009
||January 3, 2013
||Israel: Ministry of Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Endocrine System Diseases
Molecular Mechanisms of Pharmacological Action