Condition category
Urological and Genital Diseases
Date applied
03/12/2007
Date assigned
18/01/2008
Last edited
04/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Muhammad Magdi Yaqoob

ORCID ID

Contact details

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

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 measures

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

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

http://www.bartsandthelondon.org.uk/

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

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19608703

Publication citations

  1. 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.

Additional files

Editorial Notes