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Colchicine for Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathy

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

colchicine

About this trial

This is an interventional treatment trial for Diabetic Nephropathy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sheba medical center, Tel hashomerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

colchicine

Arm Description

patients will receive 2 mg of colchicine daily

Outcomes

Primary Outcome Measures

24 hr urine protein collection

Secondary Outcome Measures

Full Information

NCT ID

NCT01005121

First Posted

October 29, 2009

Last Updated

January 3, 2013

Sponsor

Prof.Avi Livneh

1. Study Identification

Unique Protocol Identification Number

NCT01005121

Brief Title

Colchicine for Diabetic Nephropathy

Official Title

Colchicine for Diabetic Nephropathy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Prof.Avi Livneh

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Nephropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

colchicine

Arm Type

Experimental

Arm Description

patients will receive 2 mg of colchicine daily

Intervention Type

Drug

Intervention Name(s)

colchicine

Intervention Description

2mg, per-os, once daily for six months

Primary Outcome Measure Information:

Title

24 hr urine protein collection

Time Frame

every 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shaye Kivity, MD

Phone

03-5302436

kivitys@gmail.com

Facility Information:

Facility Name

Sheba medical center, Tel hashomer

City

Ramat gan

ZIP/Postal Code

52621

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shaye Kivity, MD

Phone

03-5302436

kivitys@gmail.com

First Name & Middle Initial & Last Name & Degree

Shaye Kivity, MD

12. IPD Sharing Statement

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Colchicine for Diabetic Nephropathy

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