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Trial record 3 of 30 for:    keto

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01255020
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : May 22, 2015
Sponsor:
Collaborator:
Beijing Fresenius Kabi Pharmaceutical Co
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE August 11, 2010
First Posted Date  ICMJE December 7, 2010
Last Update Posted Date May 22, 2015
Study Start Date  ICMJE March 2010
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2015)
The longitudinal change in residual glomerular filtration rate (GFR) [ Time Frame: Every 3 months up to 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2010)
The longitudinal change in residual glomerular filtration rate (GFR),death [ Time Frame: Every 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2010)
Peritoneal membrane transport characteristics,cardiovascular events,nutritional status,hospitalization, peritonitis episodes, any adverse drug effects [ Time Frame: Every 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Renal Protective Effects of Restricted Protein Dietary With α-keto Acid in CAPD Patients
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Renal Function Disorder
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: α-Keto Acid with restricted protein diet
  • 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.
    Intervention: Drug: Placebo plus restricted protein diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2010)
160
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01255020
Other Study ID Numbers  ICMJE KAPDRRF
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xue Qing Yu, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Beijing Fresenius Kabi Pharmaceutical Co
Investigators  ICMJE
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
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
PRS Account Sun Yat-sen University
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP