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Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate (SEED)

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Chen Xiangmei, Chinese PLA General Hospital
Sponsor:
Information provided by (Responsible Party):
Chen Xiangmei, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01779557
First received: January 29, 2013
Last updated: June 13, 2017
Last verified: January 2017
  Purpose
This study is to evaluate the effectiveness and safety of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate, investigate the proper dialysis dose for Chinese CAPD patients.

Condition Intervention Phase
Kidney Failure,Chronic Drug: Huaren Peritoneal Dialysate Drug: Baxter Peritoneal Dialysate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: The Prospective, Randomized, Parallel, Controlled, Multi-center Clinical Study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate

Further study details as provided by Chen Xiangmei, Chinese PLA General Hospital:

Primary Outcome Measures:
  • survival rate [ Time Frame: 1,2,3,4,5 years ]

Secondary Outcome Measures:
  • PD technique survival rate [ Time Frame: 1,2,3,4,5 years ]
  • estimated glomerular filtration rate decline [ Time Frame: 1,2,3,4,5 years ]
  • nutritional status [ Time Frame: 1,2,3,4,5 years ]
  • quality of life(SF-36) [ Time Frame: 1,2,3,4,5 years ]
  • cardiovascular events [ Time Frame: 1,2,3,4,5 years ]
  • increments of dialysis dose [ Time Frame: 1,2,3,4,5 years ]
  • medical costs [ Time Frame: 1,2,3,4,5 years ]
  • dropout rate [ Time Frame: 1,2,3,4,5 years ]

Other Outcome Measures:
  • AE, vital signs, laboratory tests [ Time Frame: 1,2,3,4,5 years ]
  • peritonitis [ Time Frame: 1,2,3,4,5 years ]
  • quality of products [ Time Frame: 1,2,3,4,5 years ]
  • allergy to PD fluids, bags and tubes [ Time Frame: 1,2,3,4,5 years ]

Estimated Enrollment: 750
Study Start Date: February 2013
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Huaren peritoneal dialysate
Huaren Peritoneal dialysate CAPD 3-5 times/d
Drug: Huaren Peritoneal Dialysate
Huaren Peritoneal dialysate CAPD 3-5 times/d
Active Comparator: Baxter Peritoneal Dialysate
Baxter Peritoneal dialysate CAPD 3-5 times/d
Drug: Baxter Peritoneal Dialysate
Baxter Peritoneal dialysate CAPD 3-5 times/d

Detailed Description:
This study is a prospective, randomized, parallel, controlled, multi-center clinical study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate.It aims to investigate the proper dialysis dose for Chinese CAPD patients.At the same time,it can evaluate the effectiveness and safety of Chinese product Huaren Peritoneal Dialysate and peritoneal dialysis product Baxter Peritoneal Dialysate.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18, male or female
  • Patients with end stage renal diseases
  • Dialysis mode: CAPD
  • Dialysis duration:≥30 days and ≤6 months
  • Be capable of implementing home dialysis
  • Diabetic nephropathy, 3ml/min≤ residual renal GFR ≤15ml/min; other renal diseases, 3ml/min≤ residual renal GFR ≤10ml/min
  • Sign the written informed consent

Exclusion Criteria:

  • Acute renal failure
  • Planing to receive kidney transplantation in 2 years
  • Hemodialysis
  • Exit site infection or tunnel infection
  • Presenting 2/3 of the following: a. abdominal pain, turbid ascites, with or without fever; b. drainage fluid WBC>100×106/L, neutrophil ratio>50%; c.culture positive/ Gram stain positive in drainage fluid;
  • Anti-HIV positive
  • Allergic to components of dialysate
  • Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure, anemia(Hb<80g/L),malnutrition(Serum Alb<28g/L),refractory hypertension
  • Identified peritoneal high transportation by peritoneal equilibration test (PET)
  • Extreme body shape (height> 185cm or height <145cm), obesity (BMI ≥ 33kg/m2)
  • Poor compliance
  • Pregnant or lactating, women of childbearing age do not agree to use effective contraceptive measures during the trial
  • Has a history of alcoholism and drug abuse (defined as illegal drugs)
  • Any circumstances when patients are believed unsuitable for this trial
  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: NCT01779557

Locations
China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: ZHOU Jianhui, Doctor    +86 010 66935462    china_pd@126.com   
Contact: CHEN Xiangmei, Doctor    +86 010 66935462    xmchen301@126.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Director: CHEN Xiangmei, yes Chinese PLA General Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chen Xiangmei, Professor, Chief physician, Academician of Chinese Academy of Engineering, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01779557     History of Changes
Other Study ID Numbers: HR-PD-2012
ChiCTR-TRC-13003001 ( Registry Identifier: Chinese Clinial Trial Registry )
Study First Received: January 29, 2013
Last Updated: June 13, 2017

Keywords provided by Chen Xiangmei, Chinese PLA General Hospital:
CAPD
efficacy
safety
survival rate

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Dialysis Solutions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on June 23, 2017