Diabetic NephropathiesPhase 1/2CDNTNCT02442921
Colchicine for Diabetic Nephropathy Trial
A Phase 1/2 study testing Colchicine in people with Diabetic Nephropathies, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- Colchicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Feb 2016to 30 Apr 2019
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Naomi Friedman, Ms.c contact
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 52621
Shaye Kivity, MD, 0526668134, kivitys@gmail.com
Naomi Friedman, M.sc, +972544451556, naomi.friedman@sheba.health.gov.il
About this study
Official title: The Effect of Colchicine Treatment on the Progression of Proteinuria in Patients With Diabetic Nephropathy.
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.
Read the detailed description
Diabetic nephropathy is the leading cause today for end stage renal failure in the western world. Multifactorial intervention in patients may slow the rate of albuminuria and renal injury; however several new drug trials have failed so far to significantly attenuate its progression. Several pathways are identified in the development of diabetic nephropathy, however, in recent years many researchers suspect that inflammatory pathways play central roles in the progression of diabetic neuropathy . There is compelling evidence that diabetes mellitus has an auto-inflammatory component with Nlrp3 inflammasome and interleukin -1 β activation. Colchicine is a relatively safe anti-inflammatory drug used to treat and reverse albuminuria in familial Mediterranean fever nephropathy, an auto-inflammatory disease. Data from one study demonstrated that colchicine diminished proteinuria and inflammation in experimental-diabetic animal models.
Working hypothesis and aims:
To assess whether colchicine reduces proteinuria in diabetic patients with diabetic neuropathy , despite maximal multi-factorial interventions (angiotensin-converting-enzyme inhibitors, tight glycemic and hypertensive control, lifestyle intervention, etc.).
Methods:
Forty patients with stable diabetes, and diabetic neuropathy with proteinuria of 0.5-6g/24 hours, despite standard treatment, will receive colchicine (n=20) or placebo (n=20) for 18 months. Urinary protein and creatinine clearance will be assessed three months before the study initiation, at baseline and every three months thereafter. Blood creatinine, complete blood count, creatine phosphokinase , liver function tests, fasting Glucose Test, HbA1c, and urine protein/creatinine ratio and diabetes mellitus treatment monitoring and follow-up will be performed every three months. Oral colchicine treatment will be initiated at 1mg per day, and increased gradually to 2 mg, if gastrointestinal or musculoskeletal disturbances are absent or tolerated. The participants will be called and evaluated a year after the end of treatment for all parameters mentioned. Statistical analysis will be performed by a statistician.
Expected results:
A significant reduction or stabilization of proteinuria during the 18 month treatment period, or at follow up at one year later.
Importance and Relevance to the call This study may define a new treatment for diabetic nephropathy.
- Conditions
- Diabetic Nephropathies
- Being tested
- Colchicine, Placebo
- 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
up to 2mg of Colchicine daily
PlaceboDrug
Daily placebo
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | 20 patients will receive up to 2 mg of colchicine for 18 months Receives: Drug: Colchicine |
| Placebo | Placebo comparator | 20 patients will receive placebo for 18 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of urinary protein excretion ( mg/24hrs) from baseline to 18 months.
Measured: From baseline to 18 months ( end of trial )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study start22 Feb 2016
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- D-Cure, Israel
- Responsible party
- Sponsor
- Investigators
- Shaye Kivity, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442921
- Sponsor's protocol ID
- SHEBA-2015-1560-SK-CTIL
- Acronym
- CDNT
- Status last verified
- May 2017
- First submitted
- 30 Apr 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Colchicine Treatment on the Progression of Proteinuria in Patients With Diabetic Nephropathy.
- ClinicalTrials.gov ID
- NCT02442921
- Acronym / sponsor ID
- CDNT / SHEBA-2015-1560-SK-CTIL
- Conditions
- Diabetic Nephropathies
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- D-Cure, Israel
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 13 May 2015 (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.
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.
Detailed description
Diabetic nephropathy is the leading cause today for end stage renal failure in the western world. Multifactorial intervention in patients may slow the rate of albuminuria and renal injury; however several new drug trials have failed so far to significantly attenuate its progression. Several pathways are identified in the development of diabetic nephropathy, however, in recent years many researchers suspect that inflammatory pathways play central roles in the progression of diabetic neuropathy . There is compelling evidence that diabetes mellitus has an auto-inflammatory component with Nlrp3 inflammasome and interleukin -1 β activation. Colchicine is a relatively safe anti-inflammatory drug used to treat and reverse albuminuria in familial Mediterranean fever nephropathy, an auto-inflammatory disease. Data from one study demonstrated that colchicine diminished proteinuria and inflammation in experimental-diabetic animal models.
Working hypothesis and aims:
To assess whether colchicine reduces proteinuria in diabetic patients with diabetic neuropathy , despite maximal multi-factorial interventions (angiotensin-converting-enzyme inhibitors, tight glycemic and hypertensive control, lifestyle intervention, etc.).
Methods:
Forty patients with stable diabetes, and diabetic neuropathy with proteinuria of 0.5-6g/24 hours, despite standard treatment, will receive colchicine (n=20) or placebo (n=20) for 18 months. Urinary protein and creatinine clearance will be assessed three months before the study initiation, at baseline and every three months thereafter. Blood creatinine, complete blood count, creatine phosphokinase , liver function tests, fasting Glucose Test, HbA1c, and urine protein/creatinine ratio and diabetes mellitus treatment monitoring and follow-up will be performed every three months. Oral colchicine treatment will be initiated at 1mg per day, and increased gradually to 2 mg, if gastrointestinal or musculoskeletal disturbances are absent or tolerated. The participants will be called and evaluated a year after the end of treatment for all parameters mentioned. Statistical analysis will be performed by a statistician.
Expected results:
A significant reduction or stabilization of proteinuria during the 18 month treatment period, or at follow up at one year later.
Importance and Relevance to the call This study may define a new treatment for diabetic nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: Colchicine20 patients will receive up to 2 mg of colchicine for 18 months |
| Placebo | Placebo comparator | Drug: Placebo20 patients will receive placebo for 18 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Colchicineup to 2mg of Colchicine daily | Drug | Colchicine |
| PlaceboDaily placebo | Drug | Placebo |
Primary outcome
Change of urinary protein excretion ( mg/24hrs) from baseline to 18 months.
Time frame: From baseline to 18 months ( end of trial )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: Yes
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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.
Naomi Friedman, Ms.c contact
Shaye Kivity, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Colchicine in people with Diabetic Nephropathies, run by Sheba Medical Center 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 5 inclusion and 7 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 9 May 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (0526668143, kivitys@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of urinary protein excretion ( mg/24hrs) from baseline to 18 months. (time frame: From baseline to 18 months ( end of trial )). 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 9 May 2017.