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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Function Disorder
• Intervention / Treatment: Drug: α-Keto Acid with restricted protein diet; Drug: Placebo plus restricted protein diet

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • GuangZhou, Guangdong, China, 510080
      • The 1st Affiliated Hospital, Sun Yet-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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; Other Names: Test Group
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.	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.; Other Names: Control Group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 11, 2010
• First Submitted That Met QC Criteria: December 6, 2010
• First Posted (Estimate): December 7, 2010

Study Record Updates

• Last Update Posted (Estimate): May 22, 2015
• Last Update Submitted That Met QC Criteria: May 20, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: α-Keto Acid; Residual Renal Function; Restricted Protein Diet
• Other Study ID Numbers: KAPDRRF