Survival on Peritoneal Dialysis (PD) Versus Hemodialysis (HD) in China

NCT01413074 | Terminated DMC

• 1 other identifier: CHN-RENAL-CTPIV-2010-106
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 7

Brief Summary

Primary Objective: The primary objective is to prospectively assess and compare survival in subjects with End Stage Renal Disease (ESRD) randomized to Peritoneal Dialysis (PD) or Hemodialysis (HD) treatment. Secondary Objectives: The secondary objectives are to prospectively assess and compare the following parameters in subjects receiving PD or HD treatment:

• Technique failure
• Cause of death
• Comorbidity status at baseline and changes throughout the study
• Change in residual renal function (RRF)
• Dialysis adequacy (i.e., Kt/Vurea)
• Change in blood pressure, hemoglobin, and S-phosphate
• Change in nutritional status
• Occurrence of bacterial and other infections
• Hospitalization, including number, duration, and underlying reason(s)
• Systemic inflammation as assessed by high-sensitivity C reactive protein (hs-CRP)
• Quality of life (QOL) Safety Objectives: To compare the nature and frequency of adverse events (AEs) and serious adverse events (SAEs), including abnormal laboratory test findings with clinical significance, in subjects receiving PD or HD treatment.

Conditions

End Stage Renal Disease

Keywords

End Stage Renal Disease; ESRD; Peritoneal Dialysis; PD; Hemodialysis; HD

Outcome Measures

Primary Outcomes (1)

• Assess and compare survival or all cause mortality in subjects undergoing PD or HD treatment

  2-5 yrs.

Secondary Outcomes (13)

• Assess and compare technique failure

  2-5 yrs.

• Residual Renal Function (RRF)

  2-5 yrs

• Dialysis Adequacy

  2-5 yrs.

• Co-morbidity Assessment

  2-5 yrs.

• Occurrence of Bacterial and Other Infections Infection rates

  2-5 yrs.

Study Arms (2)

ESRD patients receiving HD treatment

ACTIVE COMPARATOR

no investigational drug involved. Only oberseve therapy treatment

Other: Hemodialysis treatment

ESRD patients receiving PD treatment

EXPERIMENTAL

no investigational drug involved. Only oberseve therapy treatment

Other: Peritoneal Dialysis treatment

Interventions

Peritoneal Dialysis treatment OTHER

PD treatment

ESRD patients receiving PD treatment

Hemodialysis treatment OTHER

HD treatment

ESRD patients receiving HD treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of either sex, aged 18 years or older at time of randomization.
• Subjects diagnosed with ESRD (glomerular filtration rate \[GFR\] ≤ 15 mL/min/m2 body surface area \[BSA\]) and predicted by the investigator to need dialysis therapy within 10 weeks after the pre-screening period.
• Subjects who, as judged by the investigator, are able to comprehend the pre-defined, standardized, modality education program and have undertaken this education during the screening period.
• Subjects, or their legal representative, who, as judged by the investigator, are capable of being trained for home-based PD.
• Subjects, or their legal representative, who are able to understand and voluntarily sign an ICF.
• Subjects who are able to adhere to the study visit schedule and other protocol requirements.
• Subjects who are able to regularly visit a HD center for HD therapy (≥ 3 times per week).
• Subjects who, as judged by the investigator, are expected to remain on dialysis for at least 48 weeks.
• Subjects who have normal liver function, as judged by the investigator.
• Female subjects of childbearing potential who have a negative serum or urine pregnancy test at screening. Sexually active women of childbearing potential must agree to use adequate contraceptive methods, as judged by the investigator, while in the study.

You may not qualify if:

• Subjects who are HIV positive.
• Subjects who have already received a permanent PD catheter or HD access that is intended for permanent use before receiving modality education or have already received permanent dialysis. Subjects are not excluded if an access is present within 4 weeks before screening for back-up purposes or for acute treatment of life-threatening uremic symptoms, electrolyte abnormalities, or fluid overload.
• Subjects who have a serious, uncontrolled medical disorder or active infection, which, as judged by the investigator, would jeopardize their ability to receive the prescribed dialysis treatment.
• Subjects who have dementia or a mental status that would significantly affect the subject's understanding of the Informed Consent Form (ICF).
• Subjects who are pregnant, intend to become pregnant during the study period, or are breast-feeding.
• Subjects with a history of drug (defined as illicit drug use) or alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day) abuse in the 2 years before screening.
• Subjects who have previously received renal transplantation and are still being prescribed immunosuppressive therapy.
• Subjects who are currently using or have used an investigational product within five half-lives of the physiological action or 30 days, whichever is longer, before screening.
• Subjects who are unwilling or expected to be unable to fully comply with the visits and assessments required by the protocol.
• Subjects who have previously been randomized in this study.
• Subjects who are not eligible for either PD or HD, as judged by the investigator, due to:
• PD: documented extensive intra-peritoneal adhesions or other condition contraindicated for PD.
• HD: severe cardiac instability or other condition contraindicated for HD.
• Subjects who have a serious or acute condition that, as judged by the investigator, would preclude participation in the study.
• Subjects who have a malignancy requiring chemotherapy or radiation therapy.

Sponsors & Collaborators

• Baxter Healthcare Corporation: collaborator
• Vantive Health LLC: lead

Study Sites (7)

The First Affiliated Hospital , Sun Yet-Sen University

Guangzhou, Guangdong, 510080, China

Location

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

Ruijin Hospital,Shanghai Jiaotong University , School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Huashan Hospital ,Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Renji Hospital , Shanghai Jiaotong University , School of Medicine

Shanghai, Shanghai Municipality, China

Location

The First Affiliated Hospital , Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Hangzhou Hospital of Tranditional Chinese Medicine

Hangzhou, Zhejiang, 310007, China

Location

Related Publications (2)

• Ethier I, Hayat A, Pei J, Hawley CM, Johnson DW, Francis RS, Wong G, Craig JC, Viecelli AK, Htay H, Ng S, Leibowitz S, Cho Y. Peritoneal dialysis versus haemodialysis for people commencing dialysis. Cochrane Database Syst Rev. 2024 Jun 20;6(6):CD013800. doi: 10.1002/14651858.CD013800.pub2.

  PMID: 38899545 DERIVED

• Quinn RR, Lam NN. Home Dialysis in North America: The Current State. Clin J Am Soc Nephrol. 2023 Oct 1;18(10):1351-1358. doi: 10.2215/CJN.0000000000000273. Epub 2023 Jul 31.

  PMID: 37523194 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Quian Jia-Qi, Prof.

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Yu Xue-qing, Prof.

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: August 10, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (7)