Chronic Kidney Disease Albuminuric Patients Chronic Kidney Disease Albuminuria Curcuminoids
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Faculty of Pharmacy, Chiang Mai University