Patients classified to have chronic kidney disease of stage 3 and 4 and chronic metabolic acidosis (venous serum HCO3- of <21mml/L on 2 separate measurements at least 1 day apart) should be included into the study. The effect of sodium bicarbonate supplementation on renal function should be evaluated. MedDRA version: 21.0 Level: LLT Classification code 10066569 Term: Chronic acidosis System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 23.1 Level: PT Classification
Conditions
Interventions
Trade Name: Nephrotrans 840mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Natriumhydrogencarbonat
CAS Number: 144-55-8
Current Sponsor code: 5424.01.00
Other descriptive name: SODIUM BICAR
Sponsors
Medical University of Vienna, Department of Medicine III, Division of Nephrology und Dialysis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =18 years. • Renal function (measured by eGFR-MDRD) between 60 and 15mL/min/ 1.73m2. • Venous serum HCO3- of =65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
Exclusion criteria: • Malignant disease or 40 kg/m2). • Chronic sepsis (C reactive protein > 10 mg/dL). • Immunosuppressive therapy of any kind. • Poorly controlled blood pressure (>150/90mmHg despite the use of 4 agents) • Overt congestive heart failure. • Known peanut and/or soy allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Metabolic acidosis in chronic kidney disease is thought to be the result of an insufficient production of bicarbonate in the renal tubular system. Thus, the intervention of an oral exogenous bicarbonate supplementation to substitute the lacking endogenous bicarbonate seems to be rational. Patients with chronic kidney disease stage III and IV and chronic metabolic acidosis should be randomized to either receive a high dose of oral sodium bicarbonate with a serum target HCO3- level of 24±1 mmol/L or receive a rescue therapy of sodium bicarbonate with a serum target level of 20±1 mmol/L. After two years decline of renal function, as well as mortality rates and time of initiation of renal replacement therapy should be compared across study groups.;Secondary Objective: Secondary objectives of the trail are the rate of adverse events, in particular the effect of the additional daily dietary sodium load on the arterial blood pressure. ;Primary end point(s): The primary end point of the study is the effect of sodium bicarbonate supplementation on renal function (eGFR). Thus, the Null hypothesis suggests no difference in renal function across study groups after 2 years. On the contrary, a significantly higher eGFR in the interventional group compared to the control group confirms the alternative hypothesis.;Timepoint(s) of evaluation of this end point: After 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points are death rates between groups and the number of subjects proceeding to RRT (renal transplantation, hemodialysis, peritoneal dialysis) across groups. The alternative hypothesis suggests a significantly higher death rate and higher number of initiation of RRT, respectively, in the control group compared to the intervention group. The Null hypothesis confirms no difference in death rates and rates of initiation of RRT across study groups. ;Timepoint(s) of evaluation of this end point: After 24 months. | — |
Countries
Austria
Contacts
Public ContactOutpatient service, Nephrology
Medical University of Vienna, Department of Medicine III, Division of Nephrology und Dialysis
Outcome results
None listed