Renal Protective Effects of Restricted Protein Dietary With α-keto Acid in CAPD Patients

Overview

The prospective, double blind randomized, parallel control, and multi-center clinical trial will evaluate the safety and efficacy of α-keto acid with restricted protein diet on protecting residual renal function in continuous ambulatory peritoneal dialysis (CAPD) patients.

Full Title of Study: “Safety and Efficacy Evaluation of Restricted Protein Dietary Supplemented With α-keto Acid on Protecting Residual Renal Function in CAPD Patients–A Prospective, Double Blind Randomized, Parallel Control, Multi-center Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2013

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 α-keto acids may slow the loss of RRF in chronic kidney disease patients. However, these trials are small sample and short-time research. In PD patients, there is very few reports to indicate the effect of α-keto acid with restricted protein diet on RRF.

The aim of this study is to evaluate the safety and efficacy of α-keto acid with restricted protein diet on protecting residual renal function in continuous ambulatory peritoneal dialysis (CAPD) patients.This is a prospective, double blind randomized, parallel control, and multi-center clinical study. 160 patients who meet Inclusion/Exclusion criteria will be randomized into α-Keto Acid group or control group at the ratio of 1:1. The α-Keto Acid group will use compound α-Keto Acid plus restricted protein diet, while control group will use placebo plus restricted protein diet.The α-Keto Acid dosage is 100mg/kg/d daily. The restricted protein dosage is 1g/kg/d. The safety and efficacy of α-Keto Acid with restricted protein diet on RRF will be evaluated after 1 year treatment.

Interventions

  • Drug: α-Keto Acid with restricted protein diet
    • α-Keto Acid: The daily dose of compound α-Keto Acid is 100mg/kg/d. The total daily dose will be divided into three times a day. Restricted Protein Diet: Diet contain protein 1.0g/kg/d
  • Drug: Placebo plus restricted protein diet
    • placebo: The daily dose of placebo is 100mg/kg/d. The total daily dose will be divided into three times a day. Diet contain protein 1.0 g/kg/d.

Arms, Groups and Cohorts

  • Active Comparator: α-Keto Acid plus restricted protein diet
    • Participants randomized to this group will receive 12 months treatment of α-Keto Acid. The dose of α-Keto Acid is 100mg/kg per day and will divided into three times per day, and the α-Keto Acid will be asked to be taken during the meal. In addition, the participants will be asked to restrict the protein intake. The protein intake is restricted as 1g/kg/d.
  • Placebo Comparator: Placebo plus restricted protein diet
    • All participants will receive 12 months treatment of placebo, at the same time they will be asked to restrict the protein intake.The dose of placebo is 100mg/kg per day, and the protein intake is restricted as 1g/kg/d.

Clinical Trial Outcome Measures

Primary Measures

  • The longitudinal change in residual glomerular filtration rate (GFR)
    • Time Frame: Every 3 months up to 12 months

Secondary Measures

  • Peritoneal membrane transport characteristics
    • Time Frame: Every 3 months up to 12 months
  • Cardiovascular events
    • Time Frame: Every 3 months up to 12 months
  • Nutritional status
    • Time Frame: Every 3 months up to 12 months
  • Hospitalization
    • Time Frame: Every 3 months up to 12 months

Participating in This Clinical Trial

Inclusion Criteria

1. Patients on peritoneal dialysis (PD) at least three month prior to study entry.

2. Subjects of either sex, more than 18 years old, the range of age is 18 to 70 year old.

3. Residual GFR ≥ 3 ml/min/1.73m2.

4. Without α-Keto Acid therapy in recent 4 weeks.

5. 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. Patients with insufficient dialysis.

3. History of taking drug which may influence amino acid metabolism within one month(glucocorticoid, thyroxin, antithyroid drug, androgens,amino acids,et al).

4. Patients with diseases which contraindicate ketosteril.

5. Cannot control diet according to protocol.

6. Alcohol abuse or drug abuse.

7. Having malignant tumor.

8. History of psychiatric or neuropathic dysfunction.

9. Cardiac failure, with New York Heart Association (NYHA) grade III-IV or history of severe heart and cerebrovascular disease in recent one month(acute stroke, acute heart failure, Lability angina)

10. Serum albumin < 30g/l.

11. Serum calcium > 2.8mmol/l.

12. Participation in another clinic trial within last three months

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Collaborator
    • Beijing Fresenius Kabi Pharmaceutical Co
  • 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
    • Lan Chen, M.D. & Ph.D, Principal Investigator, Ruijin Hospital
    • Jianghua Chen, M.D. & Ph.D, Principal Investigator, First Affiliated Hospital of Zhejiang University
    • Zhangsuo Liu, M.D. & Ph.D, Principal Investigator, The First Affiliated Hospital of Zhengzhou University
    • Fei Xiong, M.D., Principal Investigator, Wuhan Chinese and Western Medicine Combined Hospital
    • Qinfeng Han, M.D.&Ph.D, Principal Investigator, Peking University Third Hospital

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