A Phase 4 interventional study of Mizoribine and Mycophenolate Mofetil in Kidney Transplant Immunosuppression, sponsored by Lee's Pharmaceutical Limited. Recruiting at 6 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by Lee's Pharmaceutical Limited · Phase 4, Interventional, and Treatment
This prospective, randomized controlled study is intended to enroll 152 patients in the early stages of donor kidney transplantation at six clinical centers in China between January 2023 and January 2024. All patients meeting the inclusion criteria were randomly assigned 1:1 to either Mizoribine or Mycophenolate Mofetil for 12 months. At the baseline of follow-up (before enrollment) and each follow-up point, all clinical indicators of patients were recorded to measure the therapeutic effect.
This is a multi-center, prospective, non-inferior, randomized controlled clinical study. The sick individuals and their families participating in the trial voluntarily participate and sign the "informed consent" under the premise of fully understanding the treatment plan; The treatment plan was approved by the hospital ethics committee.
A total of 152 patients from six centers nationwide will be enrolled starting from the date when the center's ethics are officially approved. The qualified recipients of donor kidney transplantation were randomly assigned 1:1 to the control group and the experimental group. The control group was treated with glucocorticoid + MPA+ tacrolimus for 12 months, and the experimental group was treated with glucocorticoid +MZR+ tacrolimus for 12 months. All subjects were followed up on the day of renal transplantation, at 1, 2 weeks and 1, 2, 3, 6, 9 and 12 months after the operation: history collection, incidence of acute rejection, survival rate of recipients, survival rate of transplanted kidney, liver and kidney function, blood routine and urine routine; Cytomegalovirus (CMV)-DNA and BK virus (BKV)-DNA copy levels were detected in blood at 1, 3, 6, 9, and 12 months after renal transplantation to assess CMV and BKV infection. Adverse reactions were recorded during follow-up.
Lee's Pharmaceutical Limited is the lead sponsor of 74 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mizoribine, glucocorticoid, tacrolimus
Drug: Mizoribine
Mycophenolate mofetil, glucocorticoid, tacrolimus
Drug: Mycophenolate Mofetil
Mizoribine+glucocorticoid+tacrolimus after kidney transplantation
Mycophenolate Mofetil+glucocorticoid+tacrolimus after kidney transplantation
Also known as: Mycophenolate Acid
Serum creatinine
Monitoring serum creatinine.
Time frame: Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months
White blood cell
Detect the count of white blood cell.
Time frame: Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months.
Cytomegalovirus DNA copies.
Detect Cytomegalovirus DNA copies in blood.
Time frame: Postoperative 3，6，12 months.
BK Virus DNA copies.
Detect BK virus DNA copies in blood and urine.
Time frame: Postoperative 3，6，12 months.
Uric Acid
Check uric acid levels.
Time frame: Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months.
Plan to share: No — No IPD shared plan.
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Studies of the drug tested here: Mizoribine
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