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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02369549
Recruitment Status : Active, not recruiting
First Posted : February 24, 2015
Last Update Posted : May 8, 2020
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 and slowing the loss of eGFR.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 518 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
Actual Study Start Date : September 2015
Actual Primary Completion Date : November 2019
Estimated Study Completion Date : May 2020

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. Change in albuminuria from baseline to 24 week (6 month) [ Time Frame: Baseline and 24 weeks (6 months) ]
    Albuminuria will be measured using urinary albumin-to-creatinine ratio from first morning urine samples. At each visit (pre-randomization, and 3- and 6-months post-randomization), urinary albumin-to-creatinine ratio is measured on two consecutive days and the average of the two values will be computed. The average of the two values will be log-transformed using the natural logarithm. 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 and 24 weeks (6 months) ]
    eGFR will be calculated using the CKD-EPI formula. The investigators will estimate the between-group difference in change in eGFR (6-month eGFR minus baseline eGFR), expressed in mL/min per 1.73m2, using linear regression.


Secondary Outcome Measures :
  1. Change in glycemic control among participants with diabetes mellitus [ Time Frame: Baseline and 24 week (6 months) ]
    The investigators will summarize the percentage of glycated hemoglobin pre-randomization and 6-months post-randomization and will present the between-group difference in change in percentage of glycated hemoglobin (6-month value minus pre-randomization value) among patients with diabetes mellitus.

  2. Renal failure composite [ Time Frame: 24 week (6 months) ]
    The investigators will report on the outcome of progressive CKD, ESRD, and death, first as a composite outcome, and then as separate components. ESRD will be defined as an eGFR <15 mL/min/1.73 m2 or the initiation of renal replacement therapy, which includes chronic dialysis or transplantation; progressive CKD will be defined as an eGFR loss of ≥ 30% (anytime during follow-up from the pre-randomization baseline value) or ESRD. Less than 10% of participants will be expected to experience these outcomes by 6 months. The focus of this analysis is to document any trends to inform the expected event rate for future studies.

  3. Change in health-related quality of life (physical composite summary) [ Time Frame: Baseline and 24 week (6 months) ]
    Health-related quality of life scores will be determined by the RAND version of the 36-Item Short Form Health Survey (SF-36) administered pre-randomization and at 3-months and 6-months post-randomization. The physical composite summary (PCS) score of the SF-36 will be examined. The between-group difference in change in score, 6-month value minus pre-randomization value, will be reported with 95% CIs.

  4. Change in health-related quality of life (mental composite summary) [ Time Frame: Baseline and 24 week (6 months) ]
    Health-related quality of life scores will be determined by the RAND version of the 36-Item Short Form Health Survey (SF-36) administered pre-randomization and at 3-months and 6-months post-randomization. The mental composite summary (MCS) score of the SF-36 will be examined. The between-group difference in change in score, 6-month value minus pre-randomization value, will be reported with 95% CIs.


Other Outcome Measures:
  1. Serum curcumin levels [ Time Frame: 12 weeks (3 months) ]
    To confirm our micro-particle curcumin was bioavailable, and to strengthen any relationship between micro-particle curcumin and any outcomes identified, serum levels of curcumin and its major metabolites will be measured in the first 30 participants 3 months after randomization (including patients taking micro-particle curcumin and those taking placebo). Serum curcumin and its major metabolites will be summarized in the first 30 participants randomized, by group. The between-group difference in average serum curcumin levels measured 3-months post-randomization will be reported with the 95% CI.

  2. Kidney failure risk subgroup [ Time Frame: Baseline and 24 week (6 months) ]
    The investigators will conduct an exploratory subgroup analysis based on a higher or lower estimated risk of kidney failure, using the kidney failure risk equation. Participants with a 2-year risk of ESRD less than 10% will be classified as lower risk, and patients with a risk of 10% or more will be classified as higher risk.



Information from the National Library of Medicine

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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


Locations
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Canada, Ontario
Population Health Research Institute
Hamilton, Ontario, Canada, L8L 0A6
Kidney Clinical Care Unit
London, Ontario, Canada, N6A 5A5
University Hospital
London, Ontario, Canada, N6A 5A5
Victoria Hospital
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
The Kidney Foundation of Canada
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Matthew Weir, Nephrologist LHSC
  Study Documents (Full-Text)

Documents provided by Matthew Weir, Lawson Health Research Institute:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthew Weir, Nephrologist, MD, FRCPC, MSc, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02369549    
Other Study ID Numbers: MPAC-CKD
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
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:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Curcumin
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