Condition category
Urological and Genital Diseases
Date applied
19/07/2006
Date assigned
19/07/2006
Last edited
19/07/2006
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

Ms Jane McKenzie

ORCID ID

Contact details

Numico Research B.V.
PO Box 7005
Wageningen
6700 CA
Netherlands
+31 (0)317 467800
Jane.McKenzie@Numico-Research.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

100059

Study information

Scientific title

Acronym

Renilon 7.5 study.

Study hypothesis

The nutritional status of patients supplemented with Renilon 7.5 for three months will be improved compared with patients who receive the standard treatment. Nutritional status will be assessed by a significant improvement after three months of treatment by the following parameters: normalized protein catabolic rate (nPCR), serum albumin, serum pre-albumin, serum creatinine and dry-body weight.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

End-stage renal disease

Intervention

Duration of intervention: three months.
Intervention group: standard therapy and in addition, a daily nutritional energy-dense (2 kcal/ml) supplement containing 7.5 g/100ml of demineralised whey protein and very low amount of minerals (especially phosphate) which provides 500 kcal of energy and 18.8 gram protein.
Control group: all subjects in the control group received standard therapy.

Intervention type

Drug

Phase

Not Specified

Drug names

Renilon 7.5

Primary outcome measures

Nutritional status as assessed by:
1. nPCR
2. Serum albumin
3. Serum pre-albumin
4. Serum creatinine
5. Dry body weight.

Secondary outcome measures

1. Phosphate binder use
2. Quality of life
3. Dietary intake
4. Blood parameters
5. Nutritional status as assessed by subjective global assessment (SGA)

Overall trial start date

01/09/2003

Overall trial end date

01/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

End-stage renal disease patients on hemodialysis treatment:
1. Requiring thrice-weekly hemodialysis for at least three months
2. Stable disease (no recent hospitalizations except for minor access-related stays)
3. C-reactive protein <20 mg/l
4. nPCR <1.0
5. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

88

Participant exclusion criteria

1. Inadequate dialysis (Kt/V <1.2)
2. Peritoneal dialysis in the last three months
3. Serum albumin >40 g/l
4. Body mass index (BMI) >30 kg/m^2
5. Use of any investigational drug
6. Nutritional supplementation within the last two months
7. Requiring complete enteral nutrition
8. Age <18 years

Recruitment start date

01/09/2003

Recruitment end date

01/09/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Numico Research B.V.,
Wageningen
6700 CA
Netherlands

Sponsor information

Organisation

Numico Research B.V. (The Netherlands)

Sponsor details

P.O. Box 7005
Wageningen
6700 CA
Netherlands

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Numico Research B.V.

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