Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/03/2006
Date assigned
22/06/2006
Last edited
20/01/2011
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

Dr Peter Choi

ORCID ID

Contact details

West London Renal and Transplant Centre
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Ghrelin treatment has beneficial effects on the disordered nutritional, cardiovascular and immunological physiology of dialysis patients.

Ethics approval

Approved by the Riverside Research Ethics Committee on 01/02/2006, reference number: 05/Q0401/132

Study design

Randomised, double-blind, placebo-controlled, crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Malnutrition or renal failure

Intervention

Subcutaneous ghrelin versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Ghrelin

Primary outcome measures

1. Blood pressure
2. Energy expenditure
3. Cytokine production

Secondary outcome measures

1. Food intake
2. Nutritional parameters

Overall trial start date

13/03/2006

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Dialysis patients at West London Renal and Transplant Centre, Hammersmith Hospital with evidence of malnutrition

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Anaemia
2. Over 75 years of age
3. Recent illness

Recruitment start date

13/03/2006

Recruitment end date

01/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

West London Renal and Transplant Centre
London
W12 0HS
United Kingdom

Sponsor information

Organisation

Hammersmith Hospitals NHS Trust (UK)

Sponsor details

Du Cane Road
London
W12 0HS
United Kingdom

Sponsor type

Government

Website

http://www.hhnt.org/trust/index.htm

Funders

Funder type

Government

Funder name

Hammersmith Hospital 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/19387475

Publication citations

  1. Results

    Ashby DR, Ford HE, Wynne KJ, Wren AM, Murphy KG, Busbridge M, Brown EA, Taube DH, Ghatei MA, Tam FW, Bloom SR, Choi P, Sustained appetite improvement in malnourished dialysis patients by daily ghrelin treatment., Kidney Int., 2009, 76, 2, 199-206, doi: 10.1038/ki.2009.114.

Additional files

Editorial Notes