EUCTR2012-001824-36-AT
Active, not recruiting
Not Applicable
ORAL SODIUM BICARBONATE SUPPLEMENTATION IN PATIENTS WITH CHRONIC METABOLIC ACIDOSIS AND CHRONIC KIDNEY DISEASE - Oral SoBic supplementation in patients with CKD
Medizinsiche Universität Wien, Klinik für Innere Medizin III, Abteilung für Nephrologie und Dialyse0 sites200 target enrollmentJune 11, 2012
DrugsNephrotrans 840mg
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medizinsiche Universität Wien, Klinik für Innere Medizin III, Abteilung für Nephrologie und Dialyse
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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