Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease

NCT02369549 | Completed Phase 3 DMC

• 1 other identifier: MPAC-CKD
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease (CKD); Micro-particle curcumin; Albuminuria

Outcome Measures

Primary Outcomes (2)

• Change in albuminuria from baseline to 24 week (6 month)

  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.

  Baseline and 24 weeks (6 months)

• Change in Estimated Glomerular Filtration rate (eGFR) from baseline to 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.

  Baseline and 24 weeks (6 months)

Secondary Outcomes (4)

• Change in glycemic control among participants with diabetes mellitus

  Baseline and 24 week (6 months)

• Renal failure composite

  24 week (6 months)

• Change in health-related quality of life (physical composite summary)

  Baseline and 24 week (6 months)

• Change in health-related quality of life (mental composite summary)

  Baseline and 24 week (6 months)

Other Outcomes (2)

• Serum curcumin levels

  12 weeks (3 months)

• Kidney failure risk subgroup

  Baseline and 24 week (6 months)

Study Arms (2)

Micro-particle curcumin

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Micro-particle Curcumin DRUG

as described in Arm

Also known as: Theracumin-Pro 300

Micro-particle curcumin

Placebo DRUG

Looks, smells, tastes and feels exactly like the Curcumin capsules.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• eGFR between 15 and 60 ml/min/1.73 m2;
• 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;
• If diabetic, is able and willing to take and record glucose levels at home;
• 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);
• 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.

You may not qualify if:

• Life expectancy \< 1 year;
• Known allergy to turmeric or its derivatives (ginger, curry, cumin, or cardamom);
• Known allergy to ingredients of the study product or placebo (microcrystalline cellulose, vegetarian capsule, vegetable grade magnesium stearate, silica;
• Pregnant or breastfeeding;
• Women of child-bearing potential who are not either surgically sterile or not postmenopausal for at least 1 year;
• Plans for transplantation during the study period;
• Receipt of hemodialysis or peritoneal dialysis in the past 3 months;
• Active peptic ulcer disease;
• Hepatobiliary disease in the past 4 weeks;
• Evidence of acute kidney injury (\>50% increase in serum creatinine in the past 30 days);
• History of significant bleeding (GI or retroperitoneal bleed requiring transfusion, or any intracranial hemorrhage in the past 6 months);
• Ongoing use of warfarin;
• Ongoing treatment with cyclophosphamide, camptothecin, mechlorethamine or doxorubicin;
• Ongoing use of anti-psychotic medication including haloperidol, aripiprazole, risperidone, ziprasidone, pimozide, and quetiapine;
• Previous participation in MPAC-CKD;

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• The Kidney Foundation of Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (4)

Population Health Research Institute

Hamilton, Ontario, L8L 0A6, Canada

Location

Kidney Clinical Care Unit

London, Ontario, N6A 5A5, Canada

Location

University Hospital

London, Ontario, N6A 5A5, Canada

Location

Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Related Publications (2)

• Weir MA, Walsh M, Cuerden MS, Sontrop JM, Urquhart BL, Lim YJ, Chambers LC, Garg AX. The effect of micro-particle curcumin on chronic kidney disease progression: the MPAC-CKD randomized clinical trial. Nephrol Dial Transplant. 2023 Sep 29;38(10):2192-2200. doi: 10.1093/ndt/gfad037.

  PMID: 36849161 DERIVED

• Weir MA, Walsh M, Cuerden MS, Sontrop JM, Chambers LC, Garg AX. Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease-1: Study Protocol for a Multicenter Clinical Trial. Can J Kidney Health Dis. 2018 Dec 5;5:2054358118813088. doi: 10.1177/2054358118813088. eCollection 2018.

  PMID: 30619615 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Albuminuria

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms

Study Officials

• Matthew Weir, Nephrologist

  LHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: February 24, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: May 15, 2020
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)