Colchicine for Diabetic Nephropathy Trial
CDNT
The Effect of Colchicine Treatment on the Progression of Proteinuria in Patients With Diabetic Nephropathy.
1 other identifier
interventional
40
1 country
1
Brief Summary
Forty patients with diabetic nephropathy will be treated with colchicine up to 2 mg, or placebo, for 18 months. A follow up will be performed after 12 additional months. The primary outcome will be a significant reduction or stabilization of proteinuria during the 18 month treatment period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2015
CompletedFirst Posted
Study publicly available on registry
May 13, 2015
CompletedStudy Start
First participant enrolled
February 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedMay 9, 2017
May 1, 2017
3.2 years
April 30, 2015
May 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change of urinary protein excretion ( mg/24hrs) from baseline to 18 months.
From baseline to 18 months ( end of trial )
Study Arms (2)
Colchicine
EXPERIMENTAL20 patients will receive up to 2 mg of colchicine for 18 months
Placebo
PLACEBO COMPARATOR20 patients will receive placebo for 18 months
Interventions
Eligibility Criteria
You may qualify if:
- Patients with diabetes mellitus , age\>18 years old, able to sign an informed consent.
- Hemoglobin A1c in the range of 6-9%, stable for last year (0.5±)
- Blood creatinine lower than 2 mg/dL.
- Blood pressure lower than 140/90 mmHg on stable anti-hypertensive treatment for at least 3 months.
- Treated with ACE or angiotensin II receptor blocker , unless contraindicated
You may not qualify if:
- Malignancy or significant heart, lung or liver disease.
- Any GI disease, inflammatory bowel disease , malnutrition ( BMI under 18 )
- Psychiatric disease
- Any muscle disease, history of rhabdomyolysis , myopathy or myositis.
- Any disease causing renal injury/proteinuria apart from diabetes mellitus
- Any inflammatory or autoimmune disease
- Any infection during the last month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheba Medical Centerlead
- D-Cure, Israelcollaborator
Study Sites (1)
Sheba Medical Center
Ramat Gan, 52621, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shaye Kivity, MD
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2015
First Posted
May 13, 2015
Study Start
February 22, 2016
Primary Completion
April 30, 2019
Study Completion
April 30, 2019
Last Updated
May 9, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share