A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

Kidney Transplantation Clinical Trial

Official title:

A Long-term, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05153915
• Other study ID #: F506-CL-0406
• Secondary ID: CTR20212679
• Status: Completed
• Phase: Phase 4
• Start date: December 30, 2021
• Est. completion date: March 14, 2024

Study information

• Verified date: March 2024
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients. This study will also monitor dose changes and tacrolimus whole blood trough levels of Modigraf based immunosuppression regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 14, 2024
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• Participant's parent(s) or their legal representative(s), and participant where applicable agrees not to participate in another interventional study while participating in the present study from 1 month before screening to the end of the study.

Exclusion Criteria:

• Participant has previously received another organ transplant.

• Participant has a high immunological risk, defined as a panel reactive antibody (PRA) score > 50% in the previous 6 months (only applicable for kidney transplantation recipients).

• Cold ischemia time of the donor kidney longer than 30 hours (only applicable for kidney transplantation recipients).

• Bilateral kidney transplantation recipients (only applicable for kidney transplantation recipients).

• Participant receives an ABO incompatible donor organ.

• Participant has significant kidney impairment, defined as having serum creatinine = 230 µmol/L (= 2.6 mg/dL) prior to transplantation (not applicable for kidney transplantation recipients).

• Participant has significant liver disease, defined as having elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or total bilirubin (TBL) levels 3 times the upper value of the normal range prior to transplantation (not applicable for liver transplantation recipients).

• Participants with malignancies or a history of malignancy within the last 5 years.

• Participant has a significant, uncontrolled systemic infection and/or severe diarrhea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus or has an active peptic ulcer.

• Recipient or donor known to be human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) positive.

• Participant requires systemic immunosuppressive medication for any indication other than transplantation.

• Participants taking or requiring to be treated with medication or substances prohibited by this protocol.

• Known allergy or intolerance to steroids, macrolide antibiotics, basiliximab, or tacrolimus.

• Participants with severe primary disease/complications/poor general condition which may be unsuitable for participating in this study.

• Participant is currently participating in another clinical trial and/or has been taking any other study drug within 1 month prior to screening.

• Participant is unlikely to comply with the visits scheduled in the protocol.

Related Conditions & MeSH terms

• Kidney Transplantation
• Liver Transplantation

Intervention

Drug:
• Tacrolimus granules
Oral

Locations

Country	Name	City	State
China	Site CN86003	Beijing
China	Site CN86006	Changsha
China	Site CN86001	Guangzhou
China	Site CN86002	Shanghai
China	Site CN86007	Tianjin
China	Site CN86004	Wuhan
China	Site CN86005	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma China, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of rejection episodes	The reporting of acute rejection includes any biopsy-proven or clinically suspected rejection of transplantation	Up to 12 months
Primary	Number of participant survivals	Participant survival status will be recorded during 12 months post-transplant.	Up to 12 months
Primary	Number of graft survivals	Graft failure is defined as graft dysfunction including re-transplantation or death.	Up to 12 months
Primary	Number of dose changes throughout the study period	The number of dose changes will be recorded throughout the study period.	Up to 12 months
Primary	Number of participants with adverse events (AEs)	An AE is defined as any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not related to the study drug.	Up to 12 months
Primary	Number of participants with laboratory value abnormalities and/or adverse events (AEs)	Number of participants with potentially clinically significant laboratory values.	Up to 12 months
Primary	Number of participants with vital sign abnormalities and/or adverse events (AEs)	Number of participants with potentially clinically significant vital sign values.	Up to 12 months
Primary	Number of participants with elecrocardiogram (ECG) abnormalities and/or adverse events (AEs)	Number of participants with potentially clinically significant ECG values.	Up to 12 months
Primary	Assess levels of tacrolimus whole blood trough using a local assay method	Tacrolimus whole blood trough levels are routinely monitored using a local assay method, for example EMITÒ or Liquid-Chromatography-Mass-Spectrometry-Mass-Spectrometry (LC-MS-MS) in the local laboratories.	Up to 12 months