Correction of acidosis in chronic kidney disease (CKD)

ISRCTN	ISRCTN17109689
DOI	https://doi.org/10.1186/ISRCTN17109689
Protocol serial number	P/01/211
Sponsor	Barts and the London NHS Trust (UK)
Funder	Barts and the London NHS Trust (UK)

Submission date: 03/12/2007
Registration date: 18/01/2008
Last edited: 04/07/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Muhammad Magdi Yaqoob
Scientific

Renal Unit
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised prospective parallel group study of patients in stage 4 and 5 CKD
Secondary study design	Randomised controlled trial
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)
Study objectives	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(s)	The study is approved by the Local Research Ethics Committee from April 2002 to July 2006 (ref: P/01/211).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Sodium bicarbonate
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/07/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	134
Key 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
Key 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
Date of first enrolment	30/04/2002
Date of final enrolment	30/07/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Renal Unit

London
E1 1BB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2009		Yes	No