Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease (MPAC-CKD)
Chronic Kidney Disease
About this trial
This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease (CKD), Micro-particle curcumin, Albuminuria
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Current participation on another investigational medication trial.
Sites / Locations
- Population Health Research Institute
- Kidney Clinical Care Unit
- University Hospital
- Victoria Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Micro-particle curcumin
Placebo
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.
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.