Condition category
Urological and Genital Diseases
Date applied
26/02/2007
Date assigned
14/06/2007
Last edited
14/06/2007
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

Prof Bruno Cianciaruso

ORCID ID

Contact details

University Federico II of Naples
Division of Nephrology
Building N°5
Via S. Pansini N°5
Naples
80131
Italy
cianciar@unina.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

00138

Study information

Scientific title

Acronym

Study hypothesis

To test the best metabolic control of renal failure with a low protein diet.

Ethics approval

Approval received from the ethics board of the University of Naples on the 15th April 1998 (ref: 29/98).

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Nephrology; chronic kidney disease, renal failure, uraemia

Intervention

Two diets with different protein content: 0.55 g/kg/day versus 0.80 g/kg/day.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Blood levels of urea

Secondary outcome measures

1. Plasma/serum levels of phosphate
2. Parathyroid hormone
3. Bicarbonate levels

Overall trial start date

01/01/1999

Overall trial end date

31/12/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age of 18 years
2. A basal value of estimated Glomerular Filtration Rate (eGFR) equal or less than 30 ml/min/1.73 m^2
3. After a three months baseline period the patients with stable renal function were deemed eligible for study

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

420

Participant exclusion criteria

1. Unstable renal function
2. Malignant disease, if treated with immunosuppressant drugs, or urinary protein excretion exceeding 5 g/24 hours
3. Pregnancy

Recruitment start date

01/01/1999

Recruitment end date

31/12/2002

Locations

Countries of recruitment

Italy

Trial participating centre

University Federico II of Naples
Naples
80131
Italy

Sponsor information

Organisation

University Federico II of Naples (Italy)

Sponsor details

School of Medicine
Via s. Pansini N°5
Naples
80131
Italy
cianciar@unina.it

Sponsor type

University/education

Website

http://www.unina.it/

Funders

Funder type

Government

Funder name

Partially funded in an unrestricted manner by the Plans of Important National Interest (Progetti di Rilevante Interesse Nazionale) (PRIN) - 2001(ref: 061427) of the Italian Ministry of Universities (Italy)

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