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

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ClinicalTrials.gov Identifier: NCT01779557
Recruitment Status : Recruiting
First Posted : January 30, 2013
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Chen Xiangmei, Chinese PLA General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Failure,Chronic Drug: Huaren Peritoneal Dialysate Drug: Baxter Peritoneal Dialysate Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Prospective, Randomized, Parallel, Controlled, Multi-center Clinical Study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate
Study Start Date : February 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
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



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

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

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


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 )
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: January 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