Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Renal Function in PD Patients

Overview

This randomized, open-label, prospective study will evaluate the renal effective effect of compound α-Keto Acid plus low protein diet in PD Patients.

Full Title of Study: “Randomized, Open-Label, Prospective Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Residual Renal Function (RRF) in Peritoneal Dialysis Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2009

Detailed Description

Residual renal function (RRF) is associated with cardiovascular complication, nutritional status, incidence of peritonitis, and quality of life in peritoneal dialysis (PD) patients. Therefore, RRF is an important determinant of mortality and morbidity in PD patients.

Previous studies have suggested that dietary protein restriction supplemented with compound keto/amino acids may slow the loss of RRF in chronic kidney disease patients. However, there is very few reports to address the effect of compound keto/amino acid supplementation in RRF in PD patients.

The aim of this study is to evaluate the protective effect of compound α-Keto Acid plus low protein diet in RRF in PD Patients.This is a randomized, open-label, prospective study. 100 patients who meet Inclusion/Exclusion criteria will be randomized into α-Keto Acid group or control group at the ratio of 1:1. α-Keto Acid group will use compound α-Keto Acid plus low protein diet, while control group will use normal protein diet.Compound α-Keto Acid dosage is 0.1/kg/d daily. The effect of compound α-Keto Acid plus low protein diet in RRF will be evaluated after 1 year treatment.

Interventions

  • Dietary Supplement: α-Keto Acid with low protein diet
    • Compound α-Keto Acid: The daily dose of compound α-Keto Acid is 0.1/kg/d. The total daily dose will be divided into three times a day. Low Protein Diet: Diet contain protein 0.8g/kg/d.
  • Dietary Supplement: Normal protein diet
    • Diet contain protein 1.0-1.2 g/kg/d.

Arms, Groups and Cohorts

  • Active Comparator: 1
    • α-Keto Acid plus low protein diet
  • Other: 2
    • Normal protein diet

Clinical Trial Outcome Measures

Primary Measures

  • The longitudinal change in residual glomerular filtration rate (GFR),residual urine volume
    • Time Frame: Every 3 months

Secondary Measures

  • Peritoneal membrane transport characteristics,cardiovascular events,nutritional status,hospitalization, peritonitis episodes, any adverse drug effects.
    • Time Frame: Every 3 months

Participating in This Clinical Trial

Inclusion Criteria

1. Patients on PD at least one month prior to study entry.

2. Subjects of either sex, more than 20 years old, the range of age is 20 to 75 year old.

3. Residual GFR ≥3 ml/min/1.73m2.

4. Residual urine volume ≥ 500 ml/24h.

5. No history of taking α-Keto Acid within 2 weeks.

6. Subjects who agree to participate in the study and sign the informed consent.

Exclusion Criteria

1. History of peritonitis or other infection within one month.

2. History of taking drug which may affect amino acid metabolism within one month.

3. Incapable of following study requirements to control diet.

4. With severe cardiovascular disease, chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse.

5. Participation in another clinic trial within one month prior to screening.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xue Qing Yu, Professor – Sun Yat-sen University
  • Overall Official(s)
    • Xueqing Yu, M.D. & Ph.D., Principal Investigator, 1st Affiliated Hospital, Sun Yat-Sen University

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