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Curcumin, in Addition to Standard of Care, on Albuminuria and Kidney Outcomes Among Patients with Chronic Kidney Disease

Efficacy, Safety, and Cost-Utility of Curcumin, in Addition to Standard of Care, on Albuminuria and Kidney Outcomes Among Patients with Chronic Kidney Disease: A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250906001
Enrollment
540
Registered
2025-09-06
Start date
2025-09-08
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease Albuminuric Patients Chronic Kidney Disease Albuminuria Curcuminoids

Interventions

Participants will be randomly assigned to receive a 500 mg film-coated tablet of curcumin 3 times a day (total 1,500 mg/day) in addition to the standard of care,Participants will be randomly assigned
Curcumin film-coated tablet,Placebo

Sponsors

Health Systems Research Institute (HSRI), Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 20 years or over at the date of screening, 2. Diagnosed with CKD stage 3-4 (eGFR 15-59 mL/min/1.73 m2), 3. Albuminuria (UACR 30-5,000 mg/g), 4. Serum potassium <5 mmol/L or asymptomatic mild hyperkalemia (5.0-5.5 mmol/L) treated with potassium exchange resin, 5. Treated with ACEIs/ARBs with stable doses for 4 weeks or more before recruitment or intolerant/contraindicated to ACEIs/ARBs

Exclusion criteria

Exclusion criteria: 1. Inability to answer questions or comply with the study protocol due to physical or mental disability, 2. Recent hospitalization within 3 months, 3. Active malignancy or prognosis for survival of less than 12 months, 4. Type 1 diabetes/ANCA-associated with vasculitis/active glomerulonephritis, 5. Pregnancy (or planned within 1 year)/lactation, 6. History of biliary obstruction/hepatic impairment (AST/ALT >3 times the upper limit of normal or total bilirubin >1.5 times the upper limit of normal) or allergy to turmeric/curcumin compounds, 7. Uncontrolled psychiatric disorders/non-compliance with treatment, 8. Currently treated with oral anticoagulant, chemotherapeutic agents (cyclophosphamide, camptothecin, mechlorethamine, doxorubicin), antipsychotic drugs (haloperidol, aripiprazole, risperidone, ziprasidone, pimozide, quetiapine)

Design outcomes

Primary

MeasureTime frame
urine albumin-to-creatinine ratio (UACR, mg/g) at 0, 2, 4, 6, 9, and 12 months random urine,Estimated glomerular filtration rate (eGFR, mL/min/1.73 m2) at 0, 2,4,6,9,12 months CKD-EPI equation

Secondary

MeasureTime frame
Blood pressure at 0, 2, 4, 6, 9, 12 months Calibrated approach as recommended by guidelines ,Blood glucose (fasting blood sugar, HbA1c) at 0, 2, 4, 6, 9, 12 months Based on validated methods as per protocol of each hospital setting,urine analysis (quinulinic acid, 5-HIAA, kynurenic acid) at 0, 6, 12 months random urine ,High-sensitivity C-reactive protein at 0, 6, 12 months Based on validated methods as per protocol of each hospital setting,Complete blood count (WBC, RBC, Hg/Hct, Platelet, Neutrophil, Lymphocyte, Monocyte, Eosinophil, MCV, MCH, MCHC) at 0, 2, 4, 6, 9, 12 months Based on validated methods as per protocol of each hospital setting,Serum creatinine at 0, 2, 4, 6, 9, 12 months Based on validated methods of blood chemistry as per protocol of each hospital setting,Blood urea nitrogen at 0, 2, 4, 6, 9, 12 months Based on validated methods of blood chemistry as per protocol of each hospital setting,Blood chemistry, electrulytes (Na, K, Cl, CO2, Ca, P, Mg) at 0, 2, 4, 6, 9, 12 months Based on validated methods of blood chemistry as per protocol of each hospital setting,Serum albumin at 0, 2, 4, 6, 9, 12 months Based on validated methods as per protocol of each hospital setting,Ferritin at 0, 6, 12 months Based on validated methods as per protocol of each hospital setting,Total iron-binding capacity at 0, 6, 12 months Based on validated methods as per protocol of each hospital setting,Parathyroid hormone at 0, 6, 12 months Based on validated methods as per protocol of each hospital setting,Uric acid at 0, 6, 12 months Based on validated methods as per protocol of each hospital setting,Liver function test (AST, ALT, total/direct bilirubin) at 0, 2, 4, 6, 9, 12 months Based on validated methods as per protocol of each hospital setting,Cognitive function at 0, 6, 12 months MMSE-Thai,Nutrition assessment at 0, 6, 12 months Subjective Global Assessment,Stool Form at 0, 2, 4, 6, 9, 12 months Bristol Stool Form Scale,Health utility at 0, 6, 12 months EQ-5D-5L,D

Countries

Thailand

Contacts

Public ContactSurapon Nochaiwong

Faculty of Pharmacy, Chiang Mai University

surapon.nochaiwong@cmu.ac.th6653944 342

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026