ORAL SODIUM BICARBONATE SUPPLEMENTATION IN PATIENTS WITH CHRONIC METABOLIC ACIDOSIS AND CHRONIC KIDNEY DISEASE

• Conditions: 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: 14.1Level: LLTClassification code 10066569Term: Chronic acidosisSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-001824-36-AT
• Lead Sponsor: Medizinsiche Universität Wien, Klinik für Innere Medizin III, Abteilung für Nephrologie und Dialyse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-11
• Last Update Posted: 7 August 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age =18 years.
• Renal function (measured by eGFR-MDRD) between 60 and 15mL/min/ 1.73m2.
• Venous serum HCO3- of <21mml/L on two consecutive measurements, at least one day apart.
• Stable condition.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

• Malignant disease or <5years after a successfully treated malignant disease (except dermal malignancies and carcinoma in situ of the cervix declared to be cured).
• Morbid obesity (BMI >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified