Diabetic NephropathyPhase 2NCT01005121
Colchicine for Diabetic Nephropathy
A Phase 2 study testing colchicine in people with Diabetic Nephropathy, run by Prof.Avi Livneh at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- colchicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2009to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba medical center, Tel hashomer
Ramat Gan, 52621
Shaye Kivity, MD, 03-5302436, kivitys@gmail.com
Shaye Kivity, MD
About this study
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.
- Conditions
- Diabetic Nephropathy
- Being tested
- colchicine
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colchicineDrug
2mg, per-os, once daily for six months
| Study group | Role | What they receive |
|---|---|---|
| colchicine | Experimental | patients will receive 2 mg of colchicine daily Receives: Drug: colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hr urine protein collection
Measured: every 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof.Avi Livneh
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Prof.Avi Livneh, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005121
- Sponsor's protocol ID
- SHEBA-09-7369-AL-CTIL
- Status last verified
- Jan 2013
- First submitted
- 29 Oct 2009
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine for Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT01005121
- Acronym / sponsor ID
- SHEBA-09-7369-AL-CTIL
- Conditions
- Diabetic Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Prof.Avi LivnehOther government
- Study start
- Dec 2009
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colchicine | Experimental | Drug: colchicinepatients will receive 2 mg of colchicine daily |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colchicine2mg, per-os, once daily for six months | Drug | colchicine |
Primary outcome
24 hr urine protein collection
Time frame: every 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
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Diabetic Nephropathies MeSH:D003928, Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing colchicine in people with Diabetic Nephropathy, run by Prof.Avi Livneh at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaye Kivity, MD (03-5302436, kivitys@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hr urine protein collection (time frame: every 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.