Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China

NCT ID: NCT02378350

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 668 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-26
• Study Completion Date: 2017-09-18

Brief Summary

This is a multicenter, randomized, open-label study to compare QoL in subjects with end-stage renal disease (ESRD) requiring PD or conventional in-center HD treatment.

Primary Objective: The primary objective is to demonstrate non-inferiority of peritoneal dialysis (PD) treatment as compared to hemodialysis (HD) treatment after approximately 1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire domain of burden of kidney disease.

Secondary Objectives: The secondary objectives are to observe and summarize the following parameters in subjects receiving PD or HD treatment except for the remaining domains of QoL instrument KDQoL-SF™ (version 1.3) and the 2 individual QoL items scored as single items, which will be compared between the 2 treatment groups:

• Mortality rates
• Switch (PD to HD or HD to PD)
• Transplantation rate
• Cause of death
• Dialysis adequacy (ie, urea clearance time normalized by total body water, which is the volume of distribution of urea [Kt/V urea] to determine the proportion of subjects meeting standards of care for dialysis adequacy).
• 24-hour urine volume
• Change in hemoglobin and S-phosphate levels, and the percentages of subjects with values within the target range
• Change in serum albumin
• Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ESRD patients receiving HD treatment

no investigational drug involved. Only observe therapy treatment

Group Type: ACTIVE_COMPARATOR

Hemodialysis treatment (no specific device is defined)

Intervention Type: DEVICE

ESRD patients receiving PD treatment

no investigational drug involved. Only observe therapy treatment

Group Type: EXPERIMENTAL

Peritoneal Dialysis treatment (no specific drug is defined)

Intervention Type: DRUG

Interventions

Hemodialysis treatment (no specific device is defined)

Intervention Type: DEVICE

Peritoneal Dialysis treatment (no specific drug is defined)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects or their legal representative who are able to understand and have voluntarily signed the informed consent form (ICF)

2. Male or female subjects aged 18 years or older at the time of randomization

3. Subjects diagnosed with ESRD (ie, an estimated glomerular filtration rate ≤15 mL/min/1.73 m2 body surface area) and who the Investigator anticipates will require maintenance dialysis therapy within 10 weeks after signing the ICF

4. Subjects who, as judged by the Investigator, are able to comprehend the standardized, predialysis education program and have completed this education prior to signing the ICF

5. Subjects or their legal representative who, as judged by the Investigator, are capable of being trained for home-based PD

6. Subjects who are able to adhere to the study visit schedule and other protocol requirements

7. Subjects who are able to come to HD clinics as required by the protocol

8. Subjects who, as judged by the Investigator, are expected to remain on dialysis for at least 48 weeks

9. Subjects who have normal liver function, as judged by the Investigator

10. Female subjects of childbearing potential must have 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

Exclusion Criteria

1. Subjects who are HIV positive

2. Subjects who have already received maintenance dialysis. Subjects are not excluded if a functional dialysis access is present ≤4 weeks before Screening for back-up purposes or for acute treatment of life-threatening uremic symptoms, electrolyte abnormalities or fluid overload

3. Subjects who have an active infection or other condition that the Investigator determines may jeopardize their ability to receive either modality of dialysis treatment or would preclude participation in the study

4. Subjects who report a history of illicit drug use or a regular or daily alcohol consumption of ≥4 alcoholic drinks per day in the 2 years before Screening

5. Subjects who have previously received renal transplantation and are currently prescribed immunosuppressive therapy

6. Subjects who are currently using any investigational drug

7. Subjects who are currently enrolled in other clinical studies

8. Subjects who are unwilling or unable to fully comply with the visits and assessments required by the protocol

9. Subjects who are not eligible for either PD or HD, as judged by the Investigator, due to:

• Peritoneal dialysis: documented extensive intra-peritoneal adhesions or other conditions in which PD is contraindicated
• Hemodialysis: severe cardiac instability or other conditions in which HD is contraindicated

10. Subjects who have a malignancy requiring chemotherapy or radiation therapy

11. Subjects undergoing temporary dialysis treatment between the Screening visit and Day 1 visit that is expected to exceed 6 weeks in duration

12. Subjects who have a life expectancy of < 48 weeks

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Vantive Health LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Lanzhou University Second Hospital

Lanzhou, Gansu, China

The First Affiliated Hospital , Sun Yet-Sen University

Guangzhou, Guangdong, China

Guangzhou Panyu Central Hospital

Guangzhou, Guangdong, China

The Third Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

The 2nd Shenzhen Municipal People's Hospital

Shenzhen, Guangdong, China

Guizhou Province People's Hospital

Guiyang, Guizhou, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Traditional Chinese Medicine Hospital of Wuhan

Wuhan, Hubei, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Jiangxi province people's hospital

Nanchang, Jiangxi, China

Nanchang First Affiliated Hospital

Nanchang, Jiangxi, China

First Hospital of Affiliated of Dalian Medical University

Dalian, Liaoning, China

General Hospital of Ningxia Medical University

Yingchuan, Ningxia, China

Renji Hospital , Shanghai Jiaotong University , School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai 455 Hospital

Shanghai, Shanghai Municipality, China

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Shanghai Xinhua Hospital

Shanghai, Shanghai Municipality, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

The First Affiliated Hospital of Tianjin University of TCM

Tianjin, Tianjin Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 38899545 (View on PubMed)

Other Identifiers

8339-001

Identifier Type: -

Identifier Source: org_study_id