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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN58881100

Enrollment

420

Registered

2007-06-14

Start date

1999-01-01

Completion date

Unknown

Last updated

2019-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrology

Interventions

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

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Blood levels of urea	—

Secondary

Measure	Time frame
1. Plasma/serum levels of phosphate 2. Parathyroid hormone 3. Bicarbonate levels	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026