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Table 2 Summary of on-going randomized clinical trials of alkali therapy in patients with chronic kidney disease

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]

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

36 months

24 months

24 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

  1. Abbreviations: CKD, chronic kidney disease; Cr, creatinine; HOMA-IR, homeostasis model assessment-estimated insulin resistance; DEXA, dual energy X-ray absorptiometry; NGAL, urinary neutrophil gelatinase-associated lipocalin; KIM-1, kidney injury molecule-1; PTH, parathyroid hormone; eGFR, estimated glomerular filtrate rate; MDRD, modification of diet in renal disease; NY, New York; OH, Ohio.
  2. ^Our institution is one of the centers for the study (NCT01452412) and one of us (MKA) is a co-investigator. The information presented is updated from clinicaltrials.gov.
  3. #Recruitment was planned to start in October 2013.