Condition category
Urological and Genital Diseases
Date applied
13/09/2006
Date assigned
25/10/2006
Last edited
25/10/2006
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

Dr Joseph Eustace

ORCID ID

Contact details

Department of Nephrology
Cork University Hospital
Cork
-
Ireland

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

http:// www.recip.se

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

Publication citations

Additional files

Editorial Notes