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Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease-1: Study Protocol for a Multicenter Clinical
Matthew A Weir1,2,3, Michael Walsh4,5, Meaghan S Cuerden2
1Division of Nephrology, Department of Medicine, Western University, London, ON, Canada.
Insights
This study investigates micro-particle curcumin for chronic kidney disease (CKD) progression. It assesses curcumin
Area of Science:
- Nephrology
- Pharmacology
- Natural Products
Background:
- Chronic kidney disease (CKD) progression to end-stage renal disease (ESRD) is a significant complication with high mortality.
- Current treatments do not effectively address the inflammation and fibrosis driving CKD progression.
- Micro-particle curcumin, a natural product, exhibits anti-inflammatory and anti-fibrotic properties, suggesting potential therapeutic benefits for CKD.
Purpose of the Study:
- To evaluate the effect of micro-particle curcumin on key markers of CKD progression: albuminuria and estimated glomerular filtration rate (eGFR).
- To assess the feasibility of micro-particle curcumin as a treatment for patients with albuminuric CKD.
- To gather data to inform the design of a larger, international trial investigating micro-particle curcumin's potential to reduce ESRD risk.
Main Methods:
- A multicenter, double-blind, prospective, randomized controlled trial (MPAC-CKD-1).
- Enrollment of patients with CKD (eGFR 15-60 mL/min/1.73 m² and elevated albuminuria).
- Random assignment to micro-particle curcumin (90 mg daily) or placebo for 6 months, with co-primary outcomes of urinary albumin-to-creatinine ratio and eGFR changes.
Main Results:
- Patient enrollment began October 1, 2015, with 414 participants randomized by July 2018.
- Study results were anticipated for reporting in 2020.
- The trial is powered to detect specific differences in albuminuria and eGFR changes between groups.
Conclusions:
- The MPAC-CKD-1 trial is designed to determine if micro-particle curcumin can reduce albuminuria and slow eGFR decline in patients with albuminuric CKD.
- The study will assess the intervention's feasibility and inform the necessity of a larger-scale trial (MPAC-CKD-2).
- This trial is not powered to evaluate outcomes like renal replacement therapy or mortality.
Background:
The progression to end-stage renal disease (ESRD) is the most important complication of chronic kidney disease (CKD). Patients with ESRD require dialysis or transplantation to survive, incur numerous complications, and have high mortality rates. Slowing the progression of CKD is an important goal. Unfortunately, even when current treatments are appropriately applied, patients with CKD still progress to ESRD. Current treatments do not address the inflammation and fibrosis that mediate progression to ESRD, but micro-particle curcumin, a natural health product, has both anti-inflammatory and anti-fibrotic properties and may be an effective treatment for patients with CKD.
Objective:
Micro-particle curcumin for the treatment of CKD-1 (MPAC-CKD-1) will measure the effect of micro-particle curcumin on 2 important markers of CKD progression: albuminuria and estimated glomerular filtration rate (eGFR). Efficacy in either of these markers will justify a larger, international trial to investigate micro-particle curcumin's ability to lower the risk of ESRD in patients with CKD.
Design:
MPAC-CKD-1 is a multicenter, double-blind prospective randomized controlled trial.
Setting:
Four kidney disease clinics in Ontario, Canada (3 in London and 1 in Hamilton).
Patients:
We will enroll patients with CKD, defined by an eGFR between 15 and 60 mL/min/1.73 m2 and a daily albumin excretion of more than 300 mg (or a random urine sample albumin-to-creatinine ratio more than 30 mg/mmol).
Measurements:
We will measure changes in the co-primary outcomes of urinary albumin-to-creatinine ratio and eGFR at 3 months and 6 months. We will also measure compliance, safety parameters, and changes in health-related quality of life.
Methods:
Participants will be randomly assigned to receive micro-particle curcumin 90 mg once daily or matching placebo for 6 months. We will enroll at least 500 patients to exclude clinically meaningful 6-month changes in these 2 co-primary outcomes (16% difference in albuminuria, and a 2.3 mL/min/1.73 m2 between-group difference in the 6-month change in eGFR, at a two-tailed alpha of 0.025, power of 0.80).
Results:
Patient enrollment began on October 1, 2015, with 414 participants randomized as of July 2018. We expect to report the results in 2020.
Limitations:
MPAC-CKD-1 is not powered to assess outcomes such as the need for renal replacement therapy or death.
Conclusions:
MPAC-CKD-1 is a multicenter, double-blind prospective randomized controlled trial designed to test whether micro-particle curcumin reduces albuminuria and slows eGFR decline in patients with albuminuric CKD. MPAC-CKD-1 will also test the feasibility of this intervention and inform the need for a future larger scale trial (MPAC-CKD-2).
Trial Registration:
MPAC-CKD-1 is registered with U.S. National Institutes of Health at clinicaltrials.gov (NCT02369549). Protocol version 2.0, December 6, 2014.
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