Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease (MPAC-CKD)
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|ClinicalTrials.gov Identifier: NCT02369549|
Recruitment Status : Completed
First Posted : February 24, 2015
Last Update Posted : January 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Drug: Micro-particle Curcumin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||518 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||November 2019|
|Actual Study Completion Date :||May 15, 2020|
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.
Looks, smells, tastes and feels exactly like the Curcumin capsules.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Population Health Research Institute|
|Hamilton, Ontario, Canada, L8L 0A6|
|Kidney Clinical Care Unit|
|London, Ontario, Canada, N6A 5A5|
|London, Ontario, Canada, N6A 5A5|
|London, Ontario, Canada, N6A 5W9|
|Principal Investigator:||Matthew Weir, Nephrologist||LHSC|