Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CT 00-AMI-003
Study information
Scientific title
Acronym
Study hypothesis
Can health parameters be improved in patients on maintenance haemodialysis by oral supplementation with essential amino acids?
Ethics approval
Western Institutional Review Board (USA) approved on 27 November 2002 (Study number: 1033247, Invest. number: 67275).
Study design
Randomised, multicentre, double-blind, parallel, placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
End Stage Renal Disease (ESRD), and haemodialysis
Intervention
Essential amino acid supplementation/placebo treatment in haemodialysis patient for six months or until a primary end-point is reached.
Intervention type
Supplement
Phase
Not Specified
Drug names
Essential amino acid supplementation
Primary outcome measures
The primary outcome was comparing the time of the composite primary outcome of :
1. Hospitalisation, other than for uncomplicated dialysis access procedure
2. Prolonged Emergency Room (ER) visit (more than 16 hours)
3. Out of hospital death
Secondary outcome measures
Secondary efficacy analyses, for the following outcomes comparing the change in the given parameter from baseline to the last available study measurement:
1. Change in subjective global assessment
2. Change in grip strength
3. Change in quality of life measures (using Short Form 12 instrument)
4. Change in lowest post dialysis weight
Overall trial start date
09/01/2003
Overall trial end date
20/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients on maintenance haemodialysis for at least four months at high risk of hospitalisation. This is defined as:
a. no more than two weeks post discharge from an acute hospitalisation and a serum albumin below 4.0 g/dl
b. a serum albumin below 3.8 g/dl
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Patients planned for approximately 400. Patients obtained 84
Participant exclusion criteria
1. Patients who have difficulties in taking pills, due to problems swallowing or intractable vomiting
2. Patients who have a short time life expectancy or are awaiting non-cadaveric kidney transplantation
Recruitment start date
09/01/2003
Recruitment end date
20/01/2006
Locations
Countries of recruitment
United States of America
Trial participating centre
Department of Nephrology
Cork
-
Ireland
Sponsor information
Organisation
Recip AB (Sweden)
Sponsor details
Lagervägen 7
Haninge
SE -136 50
Sweden
Sponsor type
Industry
Website
Funders
Funder type
Government
Funder name
National Institute of Diabetes and Digestive and Kidney diseases (NIDDK), National Institutes of Health (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Recip AB (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Gambro Corporate Research
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