Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients
1 other identifier
interventional
284
1 country
14
Brief Summary
The purpose of this study is to confirm non-inferiority of delayed Prograf treatment to standard Prograf treatment in the incidence of delayed graft function (DGF) within 1 week between the 2 immunosuppressive (IS) treatment groups: delayed or standard Prograf together with induction therapy, and then convert to Advagraf usage in donation after cardiac (or circulatory) death (DCD) kidney transplant recipients. This study will also compare the clinical outcome within 6 month post-transplant between the 2 IS treatment groups and compare the safety throughout study period between the 2 IS treatment groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2018
Longer than P75 for phase_4
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2018
CompletedFirst Posted
Study publicly available on registry
August 23, 2018
CompletedStudy Start
First participant enrolled
October 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2022
CompletedOctober 31, 2024
October 1, 2024
3.7 years
August 22, 2018
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of delayed graft function (DGF)
DGF is defined as dialysis requirement during the first post-transplant week (7 days).
Up to Day 7 after transplantation
Secondary Outcomes (11)
Incidence of acute rejection (AR)
Up to Month 6 after transplantation
Renal function assessed by estimated glomerular filtration rate (eGFR)
Up to Month 6 after transplantation
Renal function assessed by serum creatinine
Up to Month 6 after transplantation
Renal function assessed by urea nitrogen
Up to Month 6 after transplantation
Subject survival
Up to Month 6 after transplantation
- +6 more secondary outcomes
Study Arms (2)
Standard Prograf group
EXPERIMENTALParticipants received from day 1 tacrolimus immediate-release formulation (Prograf) 0.1 - 0.15 milligrams/kilograms/day (mg/kg/day) orally at 12-hour interval (twice daily 1 hour before meal or 2 hours after meal) for approximately 1 month. At 1 month after Kidney transplant, Prograf was converted to Advagraf on a 1:1 (mg: mg) total daily dose basis. The Advagraf was administered orally once daily in the morning, 1 hour before the breakfast; the whole blood target trough level for Advagraf was maintained as 6 - 12 nanograms/milliliter(ng/mL) within months 2 to 3, and 6 - 8 ng/mL within months 4 to 6.
Delayed Prograf group
EXPERIMENTALParticipants received from day 3 to 5 Prograf 0.1 - 0.15 mg/kg/day orally at 12-hour interval (twice daily 1 hour before meal or 2 hours after meal) for approximately 1 month. At 1 month after Kidney transplant, Prograf was converted to Advagraf on a 1:1 (mg: mg) total daily dose basis. The Advagraf was administered orally once daily in the morning, 1 hour before the breakfast; the whole blood target trough level for Advagraf was maintained as 6 - 12 ng/mL within months 2 to 3, and 6 - 8 ng/mL within months 4 to 6.
Interventions
oral
oral
All participants will receive induction therapy. The dosage and administration of induction immunotherapy will be a single kind of drug determined by the investigator.
All participants will receive mycophenolic acid drugs in combination with corticosteroids. The dosage and administration of mycophenolic acid will be determined by the investigator.
All participants will receive corticosteroids in combination with mycophenolic acid drugs. The dosage and administration of corticosteroids will be determined by the investigator.
Eligibility Criteria
You may qualify if:
- Subject has end-stage kidney disease who is a suitable candidate for primary DCD kidney transplantation.
- Subject is a resident of China.
- Subject is scheduled to undergo DCD renal allograft transplantation with compatible ABO blood type.
- Subject has peak panel-reactive antibodies (PRA) \< 10% or "Negative" test result.
- Subject must be a recipient of a DCD kidney and receive the organ distributed by China Organ Transplant Response System only.
- Female subject must either:
- Be of non-childbearing potential: Postmenopausal (defined as at least 1 year without any menses for which there is no other obvious pathological or physiological cause) prior to screening, or documented surgically sterile
- Or, if of childbearing potential: Agree not to try to become pregnant throughout the study period and have a negative blood pregnancy test at screening.
- A sexually active male or female subject is utilizing highly effective forms of birth control starting at screening and throughout the study period if the risk of conception exists.
- Subject agrees not to participate in another interventional study while participating in the present study from 1 month before randomization to 1 month after the last dose of investigational drug.
You may not qualify if:
- Subject has previously received or is receiving an organ transplant other than kidney.
- Subject is receiving double-kidney transplant.
- Recipients of Maastricht Class I, II, and V donor organs.
- Recipients of Maastricht Class III and IV donor organs without a full complement of intensive care unit and intraoperative records.
- Subject has cold ischemia time of allograft \> 24 hours before kidney transplantation surgery.
- Subject has known contraindication to administration of tacrolimus (Prograf or Advagraf), or other macrolides.
- Subject is unlikely to comply with the visits scheduled in the protocol or has a history of non-compliance.
- Subject has evidence of active liver disease or the presence of a chronic active hepatitis B or C within 1 month prior to kidney transplant surgery.
- Recipient or donor is seropositive for human immunodeficiency virus.
- Subject has active systemic infection requiring the use of antimicrobial agents within 1 week prior to kidney transplant surgery.
- Subject has current malignancy or a history of malignancy (within the past 5 years), except non- metastatic basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix that has been treated successfully.
- Subject has medical or psychological conditions which would preclude compliance with the study requirements.
- Subject has any condition, including any uncontrolled disease state other than end-stage kidney disease, that constitutes an inappropriate risk or a contraindication for participation in the study, or that could interfere with the study objectives, conduction, or evaluation.
- Female subject who breastfeed or donate ova starting at screening and throughout the study period.
- Male subject who donate sperm starting at screening and throughout the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Site CN08608
Beijing, China
Site CN08619
Beijing, China
Site CN08609
Changsha, China
Site CN08604
Guangzhou, China
Site CN08614
Hangzhou, China
Site CN08617
Hangzhou, China
Site CN08610
Nanjing, China
Site CN08618
Nanjing, China
Site CN08612
Shanghai, China
Site CN08603
Tianjin, China
Site CN08621
Wenzhou, China
Site CN08602
Wuhan, China
Site CN08613
Wuhan, China
Site CN08605
Xi'an, China
Related Publications (1)
Oliveras L, Lopez-Vargas P, Melilli E, Codina S, Royuela A, Coloma Lopez A, Fava A, Manonelles A, Couceiro C, Lloberas N, Cruzado JM, Montero N. Delayed initiation or reduced initial dose of calcineurin-inhibitors for kidney transplant recipients at high risk of delayed graft function. Cochrane Database Syst Rev. 2025 Apr 8;4(4):CD014855. doi: 10.1002/14651858.CD014855.pub2.
PMID: 40197799DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma China, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2018
First Posted
August 23, 2018
Study Start
October 21, 2018
Primary Completion
July 15, 2022
Study Completion
July 15, 2022
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.