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

This study has been completed.
Sponsor:
Collaborator:
Beijing Fresenius Kabi Pharmaceutical Co
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01255020
First received: August 11, 2010
Last updated: May 20, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
Renal Function Disorder
Drug: α-Keto Acid with restricted protein diet
Drug: Placebo plus restricted protein diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • The longitudinal change in residual glomerular filtration rate (GFR) [ Time Frame: Every 3 months up to 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Peritoneal membrane transport characteristics [ Time Frame: Every 3 months up to 12 months ] [ Designated as safety issue: Yes ]
  • Cardiovascular events [ Time Frame: Every 3 months up to 12 months ] [ Designated as safety issue: Yes ]
  • Nutritional status [ Time Frame: Every 3 months up to 12 months ] [ Designated as safety issue: Yes ]
  • Hospitalization [ Time Frame: Every 3 months up to 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 160
Study Start Date: March 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Control Group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255020

Locations
China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University
GuangZhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Beijing Fresenius Kabi Pharmaceutical Co
Investigators
Principal Investigator: Xueqing YU, M.D. & Ph.D. 1st Affiliated Hospital, Sun Yat-Sen University
Principal Investigator: Lan Chen, M.D. & Ph.D Ruijin Hospital, Shanghai Jiaotong University School of Medicine
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
  More Information

No publications provided

Responsible Party: Xue Qing Yu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01255020     History of Changes
Other Study ID Numbers: KAPDRRF
Study First Received: August 11, 2010
Last Updated: May 20, 2015
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
α-Keto Acid
Restricted Protein Diet
Residual Renal Function

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 30, 2015