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Very Low Protein Diet and Renal Death in Chronic Kidney Disease (CKD)-ERIKA Study

NCT00323713 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2011-06-27

No results posted yet for this study

Summary

The purpose of this study is to determine whether the use of a very low protein diet is effective in delaying the start of chronic dialysis treatment in patients affected by chronic kidney disease (CKD).

Conditions

  • Chronic Renal Insufficiency

Interventions

BEHAVIORAL

Very low protein diet

0.3 g of proteins per kilo of body weight per day, supplemented with a mixture of essential aminoacids and chetoacids

BEHAVIORAL

Low protein diet

0.6 g of protein per kilo of body weight per day

Sponsors & Collaborators

  • Azienda Sanitaria ASL Avellino 2

    lead OTHER

Principal Investigators

  • Vincenzo Bellizzi, MD, PhD · Nephrology Unit "A. Landolfi" Hospital, Solofra (AV) Italy

  • Giuseppe Conte, MD · Division of Nephrology, Medical School, Second University of Naples, Naples, Italy

  • Ciro Gallo, MD · Biostatistics Unit, Medical School, Second University of Naples, Naples, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2011-07-31
Completion
2012-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00323713 on ClinicalTrials.gov