- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02378350
Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China
A Multicenter, Randomized, Open-Label Study of Quality of Life in Peritoneal Dialysis and Conventional In-Center Hemodialysis (ChinaQ Study)
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
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
Fujian
-
Fuzhou, Fujian, Kina
- The First Affiliated Hospital of Fujian Medical University
-
-
Gansu
-
Lanzhou, Gansu, Kina
- Lanzhou University Second Hospital
-
-
Guangdong
-
Guangzhou, Guangdong, Kina
- The Third Hospital of Sun Yat-Sen University
-
Guangzhou, Guangdong, Kina, 510080
- The First Affiliated Hospital , Sun Yet-Sen University
-
Guangzhou City, Guangdong, Kina
- Guangzhou Panyu Central Hospital
-
Shenzhen, Guangdong, Kina
- The 2nd Shenzhen Municipal People's Hospital
-
-
Guizhou
-
Gui Yang City, Guizhou, Kina
- GuiZhou Province People's Hospital
-
-
Heilongjiang
-
Harbin City, Heilongjiang, Kina
- The Second Affiliated Hospital of Harbin Medical University
-
-
Hubei
-
Wuhan City, Hubei, Kina
- Traditional Chinese Medicine Hospital of Wuhan
-
-
Hunan
-
Changsha, Hunan, Kina
- The Third Xiangya Hospital of Central South University
-
-
Jiangsu
-
Suzhou, Jiangsu, Kina
- The Second Affiliated Hospital of Soochow University
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina
- Jiangxi province people's hospital
-
Nangchang, Jiangxi, Kina
- Nanchang First Affiliated Hospital
-
-
Liaoning
-
Dalian, Liaoning, Kina
- First Hospital of Affiliated of Dalian Medical University
-
-
Ningxia
-
Yingchuan, Ningxia, Kina
- General Hospital of Ningxia Medical University
-
-
Shanghai
-
Shanghai, Shanghai, Kina
- Shanghai Xinhua hospital
-
Shanghai, Shanghai, Kina
- Shanghai Tenth People's Hospital
-
Shanghai, Shanghai, Kina, 200127
- Renji Hospital , Shanghai Jiaotong University , School of Medicine
-
Shanghai, Shanghai, Kina
- Shanghai 455 Hospital
-
-
Sichuan
-
Chengdu, Sichuan, Kina
- Sichuan Provincial People's Hospital
-
-
Tianjin
-
Tianjin, Tianjin, Kina
- The First Affiliated Hospital of Tianjin University of TCM
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Subjects or their legal representative who are able to understand and have voluntarily signed the informed consent form (ICF)
- Male or female subjects aged 18 years or older at the time of randomization
- 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
- 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
- Subjects or their legal representative who, as judged by the Investigator, are capable of being trained for home-based PD
- Subjects who are able to adhere to the study visit schedule and other protocol requirements
- Subjects who are able to come to HD clinics as required by the protocol
- 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 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:
- Subjects who are HIV positive
- 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
- 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
- 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
- Subjects who have previously received renal transplantation and are currently prescribed immunosuppressive therapy
- Subjects who are currently using any investigational drug
- Subjects who are currently enrolled in other clinical studies
- Subjects who are unwilling or unable to fully comply with the visits and assessments required by the protocol
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
- Subjects who have a malignancy requiring chemotherapy or radiation therapy
- Subjects undergoing temporary dialysis treatment between the Screening visit and Day 1 visit that is expected to exceed 6 weeks in duration
- Subjects who have a life expectancy of < 48 weeks
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: ESRD patients receiving HD treatment
no investigational drug involved.
Only observe therapy treatment
|
|
Eksperimentell: ESRD patients receiving PD treatment
no investigational drug involved.
Only observe therapy treatment
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire
Tidsramme: 1 year
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Mortality rates
Tidsramme: 1 year
|
1 year
|
Switch (PD to HD or HD to PD)
Tidsramme: 1 year
|
1 year
|
Transplantation rate
Tidsramme: 1 year
|
1 year
|
Cause of death
Tidsramme: 1 year
|
1 year
|
Dialysis adequacy
Tidsramme: 1 year
|
1 year
|
24-hour urine volume
Tidsramme: 1 year
|
1 year
|
Change in hemoglobin
Tidsramme: 1 year
|
1 year
|
Change in serum albumin
Tidsramme: 1 year
|
1 year
|
Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance
Tidsramme: 1 year
|
1 year
|
Change in S-phosphate levels
Tidsramme: 1 year
|
1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 8339-001
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