Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Renal Protective Effects of Restricted Protein Dietary With α-keto Acid in Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Beijing Fresenius Kabi Pharmaceutical Co
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01255020
First received: August 11, 2010
Last updated: June 27, 2011
Last verified: June 2011
History of Changes
  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:

MedlinePlus related topics: Dietary Proteins
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Peritoneal membrane transport characteristics [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
  • Cardiovascular events [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
  • Nutritional status [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
  • Hospitalization [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 160
Study Start Date: March 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
α-Keto Acid plus restricted protein diet
 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: 2
Placebo plus restricted protein diet
 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 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

Contacts
Contact: Xueqing Yu, M.D.& Ph.D 8620-87766335 yuxq@mail.sysu.edu.cn
Contact: Jiangzong Pei, M.D.& Ph.D 8620-87755766 ext 8143 jx.home@medmail.com.cn

Locations
China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University Recruiting
GuangZhou, Guangdong, China, 510080
Contact: Xueqing Yu, M.D. & Ph.D    8620-87766335    yuxq@mail.sysu.edu.cn   
Contact: Jiangzong Pei, M.D. & Ph.D.    8620-87755766 ext 8143    jx.home@medmail.com.cn   
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: Li Zuo, M.D.&Ph.D Peking University First Hospital
  More Information

No publications provided

Responsible Party: Xueqing Yu/Director, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01255020     History of Changes
Other Study ID Numbers: KAPDRRF
Study First Received: August 11, 2010
Last Updated: June 27, 2011
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on March 03, 2015