Randomised controlled trial of the benefits of oral essential amino acids in haemodialysis patients at high risk for hospitalisation

ISRCTN	ISRCTN21593740
DOI	https://doi.org/10.1186/ISRCTN21593740
Protocol serial number	CT 00-AMI-003
Sponsor	Recip AB (Sweden)
Funders	National Institute of Diabetes and Digestive and Kidney diseases (NIDDK), National Institutes of Health (USA), Recip AB (Sweden), Gambro Corporate Research

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Joseph Eustace
Scientific

Department of Nephrology
Cork University Hospital
Cork
-
Ireland

Primary study design	Interventional
Study design	Randomised, multicentre, double-blind, parallel, placebo-controlled study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Can health parameters be improved in patients on maintenance haemodialysis by oral supplementation with essential amino acids?
Ethics approval(s)	Western Institutional Review Board (USA) approved on 27 November 2002 (Study number: 1033247, Invest. number: 67275).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	20/01/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	400
Key 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
Key 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
Date of first enrolment	09/01/2003
Date of final enrolment	20/01/2006

Department of Nephrology

Cork
-
Ireland

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