Metabolic effects of two low protein diets in chronic kidney disease stage four to five: a randomised controlled trial

ISRCTN	ISRCTN58881100
DOI	https://doi.org/10.1186/ISRCTN58881100
Protocol serial number	00138
Sponsor	University Federico II of Naples (Italy)
Funder	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)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Bruno Cianciaruso
Scientific

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

Email	cianciar@unina.it

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Metabolic effects of two low protein diets in chronic kidney disease stage four to five: a randomised controlled trial
Study objectives	To test the best metabolic control of renal failure with a low protein diet.
Ethics approval(s)	Approval received from the ethics board of the University of Naples on the 15th April 1998 (ref: 29/98).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Blood levels of urea
Key secondary outcome measure(s)	1. Plasma/serum levels of phosphate 2. Parathyroid hormone 3. Bicarbonate levels
Completion date	31/12/2002

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	420
Total final enrolment	423
Key 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
Key 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
Date of first enrolment	01/01/1999
Date of final enrolment	31/12/2002

University Federico II of Naples

Naples
80131
Italy

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2008	09/05/2019	Yes	No
Results article	results	01/12/2009	09/05/2019	Yes	No

09/05/2019: Publication references and total final enrolment added.