- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00510549
Comparison of the Impact of Dialysis Treatment Type on Patient Survival
A Prospective, Randomized, Multicenter, Open Label, Interventional Pilot Study To Compare Mortality, Morbidity and QOL in Hemodialysis Versus Peritoneal Dialysis Subjects
As the influence of type of dialysis on survival of end stage renal disease (ESRD) patients remains unanswered, the present study is designed (randomized, prospective, multicenter, interventional) to assess clinical outcomes, and compare mortality, morbidity, Quality of Life (QOL) and cost effectiveness between maintenance In-center Hemodialysis (ICHD) and Continuous Ambulatory Peritoneal dialysis (CAPD). These data will ultimately bring clarity on whether or not any difference in patient survival exists between the two modalities.
In order to test the feasibility of patients' willingness to be randomized to two different modality groups and retained in the randomized group, a pilot study is planned before the conduct of a main study.
This pilot study comprises of a 6 months study, plus a 6 months observation if there is possibility to switch the patients into the main study.
All ESRD patients requiring dialysis treatment within 8 weeks after a pre-study visit will be recorded in each site. Patients who provide written inform consent for collecting relevant information will be screened using certain inclusion/exclusion criteria. Eligible patients will undergo a standardized education regarding ESRD and treatment options. Thereafter the patient will be required to provide a second inform consent allowing for randomization and entrance into the study. Eligible patient will be randomized to either PD or HD treatment.
The patients will be followed for a period of 6 months, during which patients will be treated with PD or HD as prescribed at each site, while meeting the dialysis adequacy and other indicators. For the first 3 months monthly visits are required, after which an every 3 months visit is planned.
In this pilot study, the main objective is to assess the willingness of ESRD patients to be randomized to either PD or HD treatment; thereby determining if an adequate number of eligible patients can be recruited for a future large-scale study.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
-
-
-
Beijing, Čína
- Bejing No.3 Hospital
-
Shanghai, Čína
- Renji Hospital, Shanghai
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Male or female patients who are at least 18 years of age.
- Patients who have read, understood and given written informed consent after the nature of the study has been explained.
- Patients who have a diagnosis of ESRD (GFR ≤ 10 ml/min), without a permanent access for dialysis.
- Patients who are able to comprehend a modality education program.
- Patients who are judged as capable of being trained for home based PD.
- Patients as justified by their physicians requiring dialysis treatment within 6 weeks after randomization (Patients who require urgent temporary dialysis before randomization may also be eligible for recruitment after being stabilized with temporary HD or PD)
- Patients who are expected to remain on dialysis for at least 6 months.
- Patients must have a negative HIV test at screening. -
Exclusion Criteria:
- Patients that have already received a permanent catheter or access that is intended for permanent therapy use before receiving modality information, or have already received permanent dialysis (If an access is present within 4 weeks prior to screening for back-up purposes, or for acute treatment for life threatening uremic symptoms, electrolyte abnormalities or fluid overload, this does not exclude the patient from enrollment).
- Patients who previously have received renal transplantation and are still prescribed immunosuppressive therapy.
- Patients who are unwilling or unable to follow the protocol.
- Patients with concomitant participation in any other interventional study, or who have received any investigational drug, biologic or device within five half-lives of the physiological action or 30 days, whichever is longer, prior to screening.
Patients justified as not eligible for either PD or HD due to:
- PD: documented extensive intra-peritoneal adhesions, severe infective skin disorder, or other situation contradicting PD (eg., active inflammatory bowel disease)
- HD: severe cardiac instability and inability to a gain permanent vascular access.
- Patients who have a history of drug or alcohol abuse within the six months prior to entering the study
- Patients who have active systemic infections, such as tuberculosis, septicemia or systemic fungal infections.
- Patients who have malignancies requiring active chemotherapy or radiation therapy.
- The presence of other terminal illness likely to cause death within 6 months
- Patients who have any other serious acute or active conditions that in the investigator's opinion would preclude their participation in the study.
- Female patients who are pregnant, lactating or planning on becoming pregnant during the study period.
- Patients who are allergic to starch-based polymers, maltose or isomaltose
- Patients who have glycogen storage disease.
- Patients who have a significant psychiatric disorder or mental disability that could interfere with the patient's ability to provide informed consent and/or comply with protocol procedures -
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 1, PD
Peritoneal Dialysis
|
Peritoneal Dialysis: CAPD; Hemodialysis: 3 times/week
|
|
Aktivní komparátor: 2, HD
Hemodialysis
|
Peritoneal Dialysis: CAPD; Hemodialysis: 3 times/week
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
To assess willingness of ESRD patients to be randomized to either PD or HD; thereby determining if an adequate number of eligible patients can be recruited for a future large-scale study.
Časové okno: August 2008
|
August 2008
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Jia-Qi QIAN, Prof, Center for one Baxter -Tel: 8004229837
- Vrchní vyšetřovatel: Tao Wang, Prof, Center for one Baxter -Tel: 8004229837
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SurvivalHD/PDFinal 28/03/2007
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Konečné stadium onemocnění ledvin
-
Ionis Pharmaceuticals, Inc.BayerDokončenoEnd-stage Renal Disease (ESRD)Španělsko
-
National Taiwan University HospitalNeznámý
-
Ottawa Hospital Research InstituteHeart and Stroke Foundation of OntarioDokončenoEnd-stage Renal Disease (ESRD) | Nemoc ledvinKanada
-
Ionis Pharmaceuticals, Inc.BayerDokončenoEnd-stage Renal Disease (ESRD)Kanada
-
Rockwell Medical Technologies, Inc.DokončenoEnd-stage Renal Disease (ESRD)Spojené státy, Kanada
-
University of Kansas Medical CenterDokončenoEnd-stage Renal Disease (ESRD) | Chronické onemocnění ledvin (CKD)Spojené státy
-
The First People's Hospital of YunnanAktivní, ne náborEnd-stage Renal Disease (ESRD) | Údržbová hemodialýza (MHD)Čína
-
Universitas Muhammadiyah SurakartaDokončenoHemodialýza | Chronické onemocnění ledvin | End-stage Renal Disease (ESRD)Indonésie
-
Shanghai 10th People's HospitalZápis na pozvánkuNutriční stav | Renální substituční terapie | End-stage Renal Disease (ESRD) | Peritoneální dialýza (PD)Čína
-
Darya ChamaniDokončenoHemodialýza | End-stage Renal Disease (ESRD)Írán
Klinické studie na Modality: Peritoneal Dialysis
-
University Hospital, GhentUniversity GhentDokončenoDiabetes mellitus 1. typuBelgie
-
University of AarhusDokončeno
-
Kaohsiung Medical University Chung-Ho Memorial...National Health Research Institutes, TaiwanNábor
-
Centre Georges Francois LeclercNáborVšechny typy metastatického solidního zhoubného bujení | Léčba 1. linie | Analýza Exome | Aktivní soubor studie EXOMA2Francie
-
Asuman KucukonerDokončenoRoztroušená skleróza-recidivující-remitujícíKrocan
-
St. Louis UniversityDokončenoFolikulární lymfomSpojené státy
-
Faculdade de Motricidade HumanaDokončenoÚnava | Cvičení | Výcvik | OkluzePortugalsko
-
NYU Langone HealthDokončenoMozkové neurologické onemocněníSpojené státy