Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease

• Status: Completed
• Trial end date: 2020-05-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); The Kidney Foundation of Canada
• Treatments: Curcumin

Criteria

Inclusion Criteria:

1. eGFR between 15 and 60 ml/min/1.73 m2;

2. 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;

3. If diabetic, is able and willing to take and record glucose levels at home;

4. 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);

5. 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.

Exclusion Criteria:

1. Life expectancy < 1 year;

2. Known allergy to turmeric or its derivatives (ginger, curry, cumin, or cardamom);

3. Known allergy to ingredients of the study product or placebo (microcrystalline cellulose, vegetarian capsule, vegetable grade magnesium stearate, silica;

4. Pregnant or breastfeeding;

5. Women of child-bearing potential who are not either surgically sterile or not postmenopausal for at least 1 year;

6. Plans for transplantation during the study period;

7. Receipt of hemodialysis or peritoneal dialysis in the past 3 months;

8. Active peptic ulcer disease;

9. Hepatobiliary disease in the past 4 weeks;

10. Evidence of acute kidney injury (>50% increase in serum creatinine in the past 30 days);

11. History of significant bleeding (GI or retroperitoneal bleed requiring transfusion, or any intracranial hemorrhage in the past 6 months);

12. Ongoing use of warfarin;

13. Ongoing treatment with cyclophosphamide, camptothecin, mechlorethamine or doxorubicin;

14. Ongoing use of anti-psychotic medication including haloperidol, aripiprazole, risperidone, ziprasidone, pimozide, and quetiapine;

15. Previous participation in MPAC-CKD;

16. Current participation on another investigational medication trial.