From: Metabolic acidosis and the progression of chronic kidney disease
Title | Correction of Metabolic Acidosis with Use of Bicarbonate in Chronic Renal Insufficiency (NCT01640119)[69] | Alkali Therapy in Chronic Kidney Disease (NCT01452412)[70]^ | Oral Sodium Bicarbonate Supplementation in Patients with Chronic Metabolic Acidosis and Chronic Kidney Disease (EUDRACT Number 2012-001824-36)[71] |
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Estimated primary completion date | 12/2013 | 1/2015 | Not available# |
Anticipated sample size | 728 | 150 | 200 |
CKD stage | Stage 3b & 4 | Stage 3 & 4 | Stage 3 & 4 |
Serum bicarbonate levels at randomization | ≥18 mEq/L | 20-26 mEq/L | <21 mEq/L |
Study design | Randomized, open label | Randomized, placebo-controlled, double blind | Randomized, open label |
Intervention | Bicarbonate administration to keep bicarbonate levels between 24–28 mEq/L | Sodium bicarbonate 0.4 mEq / kg ideal body weight per day | Sodium bicarbonate with target bicarbonate levels of 24 ± 1 mEq/L |
Control | No intervention, partial correction if bicarbonate <18 mEq/L (up to 22 mEq/L) | Placebo | Rescue therapy of sodium bicarbonate with target bicarbonate level of 20 ± 1 mEq/L |
Locations | Multiple centers in Italy | 2 centers in the United States (Bronx, NY and Cleveland, OH) | Single center in Vienna, Austria |
Follow up length | 36Â months | 24Â months | 24Â months |
Primary outcome | Doubling of Cr | HOMA-IR, sit to stand to sit speed, DEXA of wrist, urinary NGAL & KIM-1 | Means of eGFR, calculated using the 4-variable-MDRD Study equation |
Secondary outcome measures | All-cause death, start of dialysis | Glucose disposal rate by euglycemic hyperinsulinemic clamp, hand-grip strength, serum calcium, phosphate, 1,25-dihydroxyvitamin D, PTH, Cr, cystatin C, urinary albumin/Cr ratio, urinary cystatin | Death, need for renal replacement therapy, change in markers of bone metabolism |