Bicarbonate for older chronic kidney disease patients with acidosis

Phase 1

Conditions: Chronic kidney disease stages 4/5 with metabolic acidosis
MedDRA version: 17.0Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-005271-16-GB

Lead Sponsor: niversity of Dundee & NHS Tayside

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 380

Inclusion Criteria

Aged 60 and over
CKD stages 4 and 5 (measured by estimated glomerular filtration rate < 30ml/min) Serum bicarbonate/CO2 levels of <22mmol/L
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 290

Exclusion Criteria

Already taking bicarbonate therapy
Documented renal tubular acidosis (a rare, but separate condition)
On dialysis or anticipated to start within 3 months
Severe cognitive impairment precluding written informed consent
Decompensated chronic heart failure
Bisphosphonate therapy
Uncontrolled hypertension (BP>150/90 despite use of four agents unless in the opinion of the local PI there is evidence of adequate BP control from 24 hour BP monitoring, home BP monitoring or primary care BP records)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether oral bicarbonate therapy improves physical function and health-related quality of life compared to placebo in older people with Chronic Kidney Disease (CKD) and mild acidosis;Secondary Objective: To compare the impact of oral bicarbonate therapy against placebo on biochemical markers of chronic kidney disease in older people with CKD and mild acidosis<br><br>To assess whether use of oral bicarbonate therapy is associated with an excess of adverse events compared with placebo in older people with CKD and mild acidosis<br><br>To estimate the cost-effectiveness of using oral bicarbonate therapy compared with placebo in older people with CKD and mild acidosis;Primary end point(s): Change in Short Physical Performance Battery (SPPB) score between baseline and 12 months;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures