- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05153915
A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Astellas Pharma China, Inc.
- Phone Number: +86-010-8521633
- Email: astellas.registration@astellas.com
Study Locations
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-
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Beijing, China
- Site CN86003
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Changsha, China
- Site CN86006
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Guangzhou, China
- Site CN86001
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Shanghai, China
- Site CN86002
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Tianjin, China
- Site CN86007
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Wuhan, China
- Site CN86004
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Zhengzhou, China
- Site CN86005
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tacrolimus granules (Modigraf)
The first dose of Modigraf should be administered within 24 hours after reperfusion. Participants will be treated with a Modigraf-based immunosuppressive regimen. The initial daily dose of Modigraf is given in two divided doses (recommended interval 12 hours) postoperatively. Subsequent oral Modigraf doses will be adjusted by the investigator based on clinical evidence of efficacy, occurrence of AEs, and tacrolimus whole blood trough level. |
Oral
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participant survivals
Time Frame: Up to 12 months
|
Participant survival status will be recorded during 12 months post-transplant.
|
Up to 12 months
|
Number of dose changes throughout the study period
Time Frame: Up to 12 months
|
The number of dose changes will be recorded throughout the study period.
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Up to 12 months
|
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Time Frame: Up to 12 months
|
Number of participants with potentially clinically significant laboratory values.
|
Up to 12 months
|
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Time Frame: Up to 12 months
|
Number of participants with potentially clinically significant vital sign values.
|
Up to 12 months
|
Incidence of rejection episodes
Time Frame: Up to 12 months
|
The reporting of acute rejection includes any biopsy-proven or clinically suspected rejection of transplantation
|
Up to 12 months
|
Number of graft survivals
Time Frame: Up to 12 months
|
Graft failure is defined as graft dysfunction including re-transplantation or death.
|
Up to 12 months
|
Number of participants with adverse events (AEs)
Time Frame: Up to 12 months
|
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
|
Number of participants with elecrocardiogram (ECG) abnormalities and/or adverse events (AEs)
Time Frame: Up to 12 months
|
Number of participants with potentially clinically significant ECG values.
|
Up to 12 months
|
Assess levels of tacrolimus whole blood trough using a local assay method
Time Frame: Up to 12 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Manager Medical Science, Astellas Pharma China, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F506-CL-0406
- CTR20212679 (Registry Identifier: ChinaDrugTrials.org.cn)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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