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Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease (MPAC-CKD)

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ClinicalTrials.gov Identifier: NCT02369549
Recruitment Status : Recruiting
First Posted : February 24, 2015
Last Update Posted : March 22, 2017
Sponsor:
Collaborators:
The Kidney Foundation of Canada
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Matthew Weir, Lawson Health Research Institute

Brief Summary:
An investigator initiated pilot trial: two arm, double blind, placebo controlled, randomized, parallel group of approximately 750 patients with chronic kidney disease, and who have evidence of overt proteinuria, will be treated with micro-particle curcumin versus placebo over 24 weeks from start of the investigational medication date (approximately 6 months) to test whether curcumin can slow chronic kidney disease progression in patients. Three 30 mg capsules of micro-particle curcumin will be self-administered once daily in the morning to determine the the safety and efficacy of curcumin relative to placebo in reducing albuminuria, reducing urinary interleukin-18 and slowing the loss of eGFR.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Micro-particle Curcumin Drug: Placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease
Study Start Date : September 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Curcumin

Arm Intervention/treatment
Active Comparator: Micro-particle curcumin

Three 30 mg capsules once daily, self-administered for 6 months.

Curcumin is a nutraceutical, which are products isolated or purified from foods. The rhizomes of the plant Curcuma longa produces turmeric, a spice commonly used in Indian cuisine. Turmeric is comprised of three curcuminoids, of which curcumin is the most abundant. Curcumin is a polyphenol molecule that has been investigated for anti-inflammatory and anti-neoplastic properties since the 1970s.

Drug: Micro-particle Curcumin
as described in Arm
Other Name: Theracumin-Pro 300

Placebo Comparator: Placebo

Three 30 mg capsules taken once daily, self-administered for 6 months.

Placebo capsules are identical to the curcumin capsules in color, taste, smell, size and shape.

Drug: Placebo
Looks, smells, tastes and feels exactly like the Curcumin capsules.




Primary Outcome Measures :
  1. Percent difference between baseline and 24 week (6 month) albuminuria [ Time Frame: Baseline, 12 weeks (3 months), 24 weeks (6 months) ]
    The percent difference between baseline and 24 week (6 month) albuminuria will be compared between placebo and curcumin groups. Albuminuria will be standardized to the urine creatinine on a first morning urine sample. The loss of selectivity of the filtration barrier in the glomerulus is a factor common to all albuminuric CKD, regardless of etiology. Albuminuria is the cardinal manifestation of a malfunctioning filtration barrier and the spillage of albumin into renal tubules is thought to be toxic to tubular cells, resulting in further kidney damage. Therefore, in the current understanding, albuminuria is both a marker and a mediator of kidney damage. Reduction of albuminuria has repeatedly been associated with improved renal outcomes. Leaders in the field of nephrology recommend that albuminuria be used as a valuable predictor of response to therapy for the prevention of kidney failure.

  2. Change in Estimated Glomerular Filtration rate (eGFR) from baseline to 24 weeks (6 months) [ Time Frame: Baseline, 12 weeks (3 months), 24 weeks (6 months) ]
    Change in eGFR from baseline to 24 weeks (6 months) will be compared between the placebo and curcumin groups. by definition, GFR must decline for patients to develop kidney failure. There is no known influence of curcumin on creatinine generation, secretion or extrarenal elimination. eGFR is well suited to assess patients with CKD who experience fast progression to end-stage renal disease.


Secondary Outcome Measures :
  1. Glycemic control as assessed by change in the percentage of glycated hemoglobin [ Time Frame: Baseline, 12 week (3 months) and 24 week (6 months) ]
    Monitored among patients with diabetes mellitus. Curcumin use has been associated with improved glycemic control in animal models. Given the large proportion of patients with both CKD and diabetes, this outcome warrants exploration.

  2. Study agent discontinuation [ Time Frame: Every 4 weeks (averaging monthly), self-reported ]
    We will test protocol compliance through pill counts and interviews at each follow-up visit. Reasons for discontinuation will be recorded using standardized case report forms.

  3. Renal failure composite [ Time Frame: Every 4 weeks (averaging monthly) ]
    eGFR loss of 30% or end-stage renal disease or death. Given our eligibility criteria, it is likely that <10% of participants would experience these outcomes by 24 weeks(approximately 6 months). Although we will not have adequate statistical power to detect a meaningful effect of curcumin on these outcomes, we will document any trends to inform future studies.

  4. Safety as assessed by adverse events and patient-reported side effects [ Time Frame: Every 4 weeks (averaging monthly), self-reported ]
    Adverse events will be recorded through case report forms and reported to the principal investigator. Side effects will be assessed using standardized case report forms at each 4 week (monthly) visit. Participants are encouraged to contact the coordinator or investigator to report any concerns.


Other Outcome Measures:
  1. Long-term incidence of renal replacement therapy [ Time Frame: Assessed 2 years post trial close-out ]
    Long-term outcomes will be tracked using administrative data housed at the Institute for Clinical Evaluative Sciences (ICES), an independent research facility in Toronto, Ontario. ICES works with the Ontario Ministry of Health and Long-Term Care to study the impact of health care and diseases in Ontario. All subjects enrolled in MPAC-CKD will have data on hospital visits, physician services, and vital statistics recorded in health administrative databases housed at ICES.

  2. Long-term mortality [ Time Frame: Assessed 2 years post trial close-out ]
    Long-term outcomes will be tracked using administrative data housed at the Institute for Clinical Evaluative Sciences (ICES), an independent research facility in Toronto, Ontario. ICES works with the Ontario Ministry of Health and Long-Term Care to study the impact of health care and diseases in Ontario. All subjects enrolled in MPAC-CKD will have data on hospital visits, physician services, and vital statistics recorded in health administrative databases housed at ICES.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. eGFR between 15 and 60 ml/min/1.73 m2;
  2. Albuminuria, defined by the most recent measurement within the prior 3 months showing either: a) 24-hour urine collection with a minimum of 300 mg of protein, OR b) urinary albumin to creatinine ratio equivalent to a daily excretion of albumin of at least 300 mg;
  3. If diabetic, is able and willing to take and record glucose levels at home;
  4. If receiving and ACE inhibitor or angiotension II receptor blocker (ARB), the dosage must be stable for 2 weeks prior to screening. Patients not taking and ACE or ARB must have a documented medical contraindication (e.g. hyperkalemia, hypotension);
  5. Willing and able to give written informed consent for participation and provide consent for access to medical data according to local data protection laws and regulations.

Exclusion Criteria:

  1. Life expectancy < 1 year;
  2. Known allergy to turmeric or its derivatives (ginger, curry, cumin, or cardamom);
  3. Known allergy to ingredients of the study product or placebo (microcrystalline cellulose, vegetarian capsule, vegetable grade magnesium stearate, silica;
  4. Pregnant or breastfeeding;
  5. Women of child-bearing potential who are not either surgically sterile or not postmenopausal for at least 1 year;
  6. Plans for transplantation during the study period;
  7. Receipt of hemodialysis or peritoneal dialysis in the past 3 months;
  8. Active peptic ulcer disease;
  9. Hepatobiliary disease in the past 4 weeks;
  10. Evidence of acute kidney injury (>50% increase in serum creatinine in the past 30 days);
  11. History of significant bleeding (GI or retroperitoneal bleed requiring transfusion, or any intracranial hemorrhage in the past 6 months);
  12. Ongoing use of warfarin;
  13. Ongoing treatment with cyclophosphamide, camptothecin, mechlorethamine or doxorubicin;
  14. Ongoing use of anti-psychotic medication including haloperidol, aripiprazole, risperidone, ziprasidone, pimozide, and quetiapine;
  15. Previous participation in MPAC-CKD;
  16. Current participation on another investigational medication trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369549


Contacts
Contact: Virginia Schumann 519-685-8500 ext 57394 virginia.schumann@lhsc.on.ca

Locations
Canada, Ontario
Kidney Clinical Care Unit Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Matthew Weir, Nephrologist    519-663-2998    matthew.weir@lhsc.on.ca   
University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Matthew Weir, Nephrologist    519-663-2998    matthew.weir@lhsc.on.ca   
Victoria Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Amit Garg, Nephrologist    519-685-8502    amit.garg@lhsc.on.ca   
Sponsors and Collaborators
Lawson Health Research Institute
The Kidney Foundation of Canada
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Matthew Weir, Nephrologist LHSC

Responsible Party: Matthew Weir, Nephrologist, MD, FRCPC, MSc, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02369549     History of Changes
Other Study ID Numbers: MPAC-CKD
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Matthew Weir, Lawson Health Research Institute:
Chronic Kidney Disease (CKD)
Micro-particle curcumin
Albuminuria

Additional relevant MeSH terms:
Curcumin
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action