- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 4
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Fujian
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Fuzhou, Fujian, Chiny
- The First Affiliated Hospital Of Fujian Medical University
-
-
Gansu
-
Lanzhou, Gansu, Chiny
- Lanzhou University Second Hospital
-
-
Guangdong
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Guangzhou, Guangdong, Chiny
- The Third Hospital of Sun Yat-Sen University
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Guangzhou, Guangdong, Chiny, 510080
- The First Affiliated Hospital , Sun Yet-Sen University
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Guangzhou City, Guangdong, Chiny
- Guangzhou Panyu Central Hospital
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Shenzhen, Guangdong, Chiny
- The 2nd Shenzhen Municipal People's Hospital
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-
Guizhou
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Gui Yang City, Guizhou, Chiny
- GuiZhou Province People's Hospital
-
-
Heilongjiang
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Harbin City, Heilongjiang, Chiny
- The Second Affiliated Hospital of Harbin Medical University
-
-
Hubei
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Wuhan City, Hubei, Chiny
- Traditional Chinese Medicine Hospital of Wuhan
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-
Hunan
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Changsha, Hunan, Chiny
- The Third Xiangya Hospital of Central South University
-
-
Jiangsu
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Suzhou, Jiangsu, Chiny
- The Second Affiliated Hospital of Soochow University
-
-
Jiangxi
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Nanchang, Jiangxi, Chiny
- Jiangxi province people's hospital
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Nangchang, Jiangxi, Chiny
- Nanchang First Affiliated Hospital
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-
Liaoning
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Dalian, Liaoning, Chiny
- First Hospital of Affiliated of Dalian Medical University
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-
Ningxia
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Yingchuan, Ningxia, Chiny
- General Hospital of Ningxia Medical University
-
-
Shanghai
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Shanghai, Shanghai, Chiny
- Shanghai Xinhua hospital
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Shanghai, Shanghai, Chiny
- Shanghai Tenth People's Hospital
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Shanghai, Shanghai, Chiny, 200127
- Renji Hospital , Shanghai Jiaotong University , School of Medicine
-
Shanghai, Shanghai, Chiny
- Shanghai 455 Hospital
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-
Sichuan
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Chengdu, Sichuan, Chiny
- Sichuan Provincial People's Hospital
-
-
Tianjin
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Tianjin, Tianjin, Chiny
- The First Affiliated Hospital of Tianjin University of TCM
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Aktywny komparator: ESRD patients receiving HD treatment
no investigational drug involved.
Only observe therapy treatment
|
|
Eksperymentalny: ESRD patients receiving PD treatment
no investigational drug involved.
Only observe therapy treatment
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
---|---|
1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire
Ramy czasowe: 1 year
|
1 year
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
---|---|
Mortality rates
Ramy czasowe: 1 year
|
1 year
|
Switch (PD to HD or HD to PD)
Ramy czasowe: 1 year
|
1 year
|
Transplantation rate
Ramy czasowe: 1 year
|
1 year
|
Cause of death
Ramy czasowe: 1 year
|
1 year
|
Dialysis adequacy
Ramy czasowe: 1 year
|
1 year
|
24-hour urine volume
Ramy czasowe: 1 year
|
1 year
|
Change in hemoglobin
Ramy czasowe: 1 year
|
1 year
|
Change in serum albumin
Ramy czasowe: 1 year
|
1 year
|
Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance
Ramy czasowe: 1 year
|
1 year
|
Change in S-phosphate levels
Ramy czasowe: 1 year
|
1 year
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 8339-001
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