NCT02369549: MPAC-CKD

Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease

Completed Phase 3 Last updated 21 January 2021

What this trial tests

Phase 3 trial testing Micro-particle Curcumin in Chronic Kidney Disease in 518 participants. Completed in 15 May 2020.

Timeline

1 September 2015

Primary endpoint
1 November 2019

15 May 2020

Quick facts

Lead sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	518
Start date	1 September 2015
Primary completion	1 November 2019
Estimated completion	15 May 2020
Sites	4 locations across Canada

Drugs / interventions tested

• Micro-particle Curcumin — full drug profile →
• Placebo

Conditions studied

• Chronic Kidney Disease — all drugs for Chronic Kidney Disease →

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Who can join

18 and older, any sex, with Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 i
• 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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic Applications of Curcumin Nanoformulations.
   Yallapu MM, Nagesh PK, Jaggi M, Chauhan SC. · · 2015 · cited 195× · PMID 26335307 · DOI 10.1208/s12248-015-9811-z
2. Protective Role of Nrf2 in Renal Disease.
   Guerrero-Hue M, Rayego-Mateos S, Vázquez-Carballo C, Palomino-Antolín A, et al · · 2020 · cited 74× · PMID 33396350 · DOI 10.3390/antiox10010039
3. Therapeutic Potential and Recent Advances of Curcumin in the Treatment of Aging-Associated Diseases.
   Sundar Dhilip Kumar S, Houreld NN, Abrahamse H. · · 2018 · cited 57× · PMID 29621160 · DOI 10.3390/molecules23040835
4. Therapeutic Potential of Curcumin for the Treatment of Brain Tumors.
   Klinger NV, Mittal S. · · 2016 · cited 52× · PMID 27807473 · DOI 10.1155/2016/9324085
5. Reconnoitering the Therapeutic Role of Curcumin in Disease Prevention and Treatment: Lessons Learnt and Future Directions.
   Sivani BM, Azzeh M, Patnaik R, Pantea Stoian A, et al · · 2022 · cited 26× · PMID 35888763 · DOI 10.3390/metabo12070639
6. The Mitochondrion: A Promising Target for Kidney Disease.
   Tanriover C, Copur S, Ucku D, Cakir AB, et al · · 2023 · cited 19× · PMID 36839892 · DOI 10.3390/pharmaceutics15020570
7. Phytochemicals Targeting BDNF Signaling for Treating Neurological Disorders.
   Singh AA, Katiyar S, Song M. · · 2025 · cited 12× · PMID 40149774 · DOI 10.3390/brainsci15030252
8. Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease-1: Study Protocol for a Multicenter Clinical Trial.
   Weir MA, Walsh M, Cuerden MS, Sontrop JM, et al · · 2018 · cited 10× · PMID 30619615 · DOI 10.1177/2054358118813088