Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P/01/211
Study information
Scientific title
Effects on progression of renal failure and nutritional status by correction of metabolic acidosis in patients with non-dialysis dependent chronic kidney disease (CKD)
Acronym
Study hypothesis
Experimental data suggest that acidosis induced excessive renal ammoniagenesis and activation of the complement cascade by the alternative pathway, lead to rapid progression of renal failure which can be attenuated by bicarbonate supplementation. Moreover, metabolic acidosis accelerates protein catabolism and causes malnutrition due to an induced negative nitrogen balance in patients with end-stage renal disease (ESRD). We propose that correction of acidosis will attenuate the progression of renal failure and will improve nutritional status in patients with non-dialysis dependent chronic kidney disease.
Ethics approval
The study is approved by the Local Research Ethics Committee from April 2002 to July 2006 (ref: P/01/211).
Study design
Randomised prospective parallel group study of patients in stage 4 and 5 CKD
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic kidney disease
Intervention
Sodium bicarbonate versus no treatment.
Duration of treatment: 2 years
Method of intake: oral
Frequency of treatment: daily 600 mg three times a day to be titrated up by 600 mg till serum biocarbonate level of greater than 21 mmol/l were achieved
Duration of follow up: 2 years
Intervention type
Drug
Phase
Not Specified
Drug names
Sodium bicarbonate
Primary outcome measure
The primary end points were number of patients reaching ESRD and rate of decline of estimated glomerular filtration rate (eGFR) by Cockroft-Gault equation and creatinine clearance (Cr Cl) (24 hours urine sample).
Primary end points are measured every three months.
Secondary outcome measures
Nutritional parameters assessed by:
1. Dietary protein intake
2. Protein catabolic rate (PCR)
3. Serum albumin
4. Mid-arm muscle circumference (MAMC)
Secondary end points measured every six months.
Overall trial start date
30/04/2002
Overall trial end date
30/07/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age greater than 18 years old
2. CKD stage 4 and 5
3. Mild to moderate metabolic acidosis (serum bicarbonate less than 21 and greater than 16 mmol/L) on two consecutive measurements
4. Stable clinical condition
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
134
Participant exclusion criteria
Patients with:
1. Malignant disease
2. Morbid obesity
3. Cognitive impairment
4. Chronic sepsis
5. Poorly controlled blood pressure (greater than 150/90 mmHg), despite use of four agents
6. Overt congestive heart failure
Recruitment start date
30/04/2002
Recruitment end date
30/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Renal Unit
London
E1 1BB
United Kingdom
Sponsor information
Organisation
Barts and the London NHS Trust (UK)
Sponsor details
c/o Gerry Leanord
Research and Development Directorate
Whitechapel
London
E1 1BB
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barts and the London NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19608703
Publication citations
-
Results
de Brito-Ashurst I, Varagunam M, Raftery MJ, Yaqoob MM, Bicarbonate supplementation slows progression of CKD and improves nutritional status., J. Am. Soc. Nephrol., 2009, 20, 9, 2075-2084, doi: 10.1681/ASN.2008111205.