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 : February 19, 2020
|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|
|Estimated Study Completion Date :||May 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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|