- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03099122
A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant (START-DCD)
A Prospective, Multi-center, Single-arm, Interventional Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant in China
Primary Objective:
To investigate the efficacy of the standard dose of Thymoglobuline® induction therapy for preventing acute rejection (AR) after transplantation among recipients of Donated after Cardiac Death (DCD) kidney transplant.
Secondary Objectives:
- To evaluate delayed graft function (DGF), graft and patient survival after kidney transplant.
- To evaluate adverse events of Thymoglobuline® throughout the study.
- To explore possible risk factors of AR and DGF in patients with DCD kidney transplant.
- To evaluate AR and DGF under different risk stratifications and explore an description optimal induction therapy regimen for recipients of DCD kidney transplant.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
-
China, Chine
- China
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion criteria :
- Male or female.
- Patient is a Chinese recipient of kidney transplant for the first time.
- Patient is a recipient of kidney allograft from Chinese donors donated after cardiac death (including kidney donated after brain death followed by circulatory death).
- Recipient's age is between 18 to 65 years old (including 18 years).
- Donor's age is more than 5 years old.
- Recipient's weight is greater than or equal to 50 kg but less than or equal to 80 kg.
- Patient fully understands the study and signs the informed consent form (ICF) prior to any study procedure.
Exclusion criteria:
- Patient is a multiple organ transplant recipient.
- Recipient with previous kidney or other organ transplant history.
- Recipient and donor have incompatible blood types.
- Recipient and donor have 5 or 6 mismatched human leucocyte antigen (HLA).
- Recipient is known to have an active infection or active chronic infection, or is seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV Ab), or human immunodeficiency virus (HIV). (Serological test results within 12 months before transplantation are acceptable.)
- Recipient with cytomegalovirus (CMV) immunoglobulin G (IgG) negative who receives an allograft from CMV IgG positive donor (CMV IgG [D+/R-]).
- Any systemic infection requiring continuous treatment at enrolment, but prophylactic treatment of CMV and/or Pneumocystis carinii pneumonia (PCP) is allowed.
- Recipient has severe thrombocytopenia or leucopenia before operation (platelet count <75,000/ul, or the number of white blood cells <3,000 cells/mm3).
- Serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma glutamine transferase (GGT) ≥3ULN (upper limit of normal) within 1 week before transplantation, and not normalized at time of transplantation.
- Recipient has a history of malignancy within 5 years.
- Recipient with history of allergy and anaphylaxes to rabbit proteins or to any excipients.
- Recipient has known contraindications to the administration of Thymoglobuline®.
- Recipient has taken other investigational drugs or prohibited therapy for this study within 1 month or 5 of half-lives from screening, whichever is longer.
- Recipient has previously used Thymoglobuline®, or has participated in any clinical trial of any other medicine or device within 30 days before signing ICF.
- Pregnant or lactating women.
- Male and female patients do not agree to practice medically acceptable contraception (i.e., barrier or pharmacologic: male patient must use condoms or his female partner must take oral contraceptives; the male partner of a female patient must use condoms ) for at least 6 months following the study treatment.
Conditions/situations such as:
- Recipient not suitable for participation, whatever the reason, as judged by the Investigator, including medical, clinical, or psychosocial conditions, or patient potentially at risk of noncompliance to study procedures.
- Donor known or suspected to have active infection before donation (such as blood cultures positive, seropositive for hepatitis B surface antigen [HBsAg], or antibody against hepatitis C virus [HCVAb], or human immunodeficiency virus [HIV]) or hypersensitive recipients (eg, panel reactive antibody [PRA] positive) before transplantation, judged by the Investigator.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Thymoglobuline
A cumulative dose of Thymoglobuline will be given intravenously, with a variable interval dose. Methylprednisolone will be given as induction therapy, according to institutional practice. Tacrolimus, mycophenolate, and prednisone will be given as maintenance therapies. |
Pharmaceutical form: creamy-white powder Route of administration: intravenous
Autres noms:
Pharmaceutical form: tablet Route of administration: oral Pharmaceutical form: powder Route of administration: intravenous Pharmaceutical form: capsule Route of administration: oral Pharmaceutical form: capsule Route of administration: oral Pharmaceutical form: tablet Route of administration: oral |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Percentage of patients with biopsy-proven acute rejection events
Délai: 6 months
|
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Percentage of delayed graft function events
Délai: 6 months
|
6 months
|
Duration of delayed graft function events
Délai: 6 months
|
6 months
|
Percentage of survived grafts
Délai: 6 months
|
6 months
|
Percentage of survived patients
Délai: 6 months
|
6 months
|
Assessment of acute rejection risk factors
Délai: 6 months
|
6 months
|
Assessment of delayed graft function risk factors
Délai: 6 months
|
6 months
|
Percentage of acute rejection events in different risk stratifications
Délai: 6 months
|
6 months
|
Percentage of delayed graft function events in different risk stratifications
Délai: 6 months
|
6 months
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies rénales
- Maladies urologiques
- Insuffisance rénale
- Insuffisance rénale chronique
- Décès
- Insuffisance rénale chronique
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents autonomes
- Agents du système nerveux périphérique
- Inhibiteurs d'enzymes
- Agents anti-inflammatoires
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Antiémétiques
- Agents gastro-intestinaux
- Glucocorticoïdes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agents antinéoplasiques, hormonaux
- Agents neuroprotecteurs
- Agents protecteurs
- Agents antibactériens
- Antibiotiques, Antinéoplasiques
- Agents antituberculeux
- Antibiotiques, Antituberculeux
- Inhibiteurs de la calcineurine
- Méthylprednisolone
- Immunoglobulines
- Prednisone
- Tacrolimus
- Acide mycophénolique
- Thymoglobuline
- Sérum antilymphocytaire
Autres numéros d'identification d'étude
- THYMOL07282
- U1111-1178-5402 (Autre identifiant: UTN)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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