- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01550445
Steroid Withdrawal Immunosuppression After Renal Transplantation
Prospective Controlled Protocol for 3 Months Steroid Withdrawal With Tacrolimus, Basiliximab, and Mycophenolate Mofetil in Renal Transplant Recipients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Those patients who fulfill the entry criteria enter in this prospective controlled trial of steroid withdrawal starting at three months after transplantation. The entry criteria include 1) no episode of clinically treated nor biopsy confirmed acute rejection up to entry; 2) serum creatinine level equal to or less than 2 mg/mL on three separate measurements; 3) no proteinuria (urine protein less than 1000 mg/24 hours; 4) tacrolimus trough level > 5 ng/ml without signs of nephrotoxicity; 5) agreement to follow the study protocol.
For the patients who enter into the protocol, prednisolone would be slowly withdrawn by 2.5 mg in every two weeks until 8 weeks after entering the protocol (5 months post-transplantation). The patients visit every week, and they are closely monitored with symptoms and signs, blood cell count, chemistry, and urinalysis.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: chang-kwon Oh, M.D
- Phone Number: 82-10-9165-7281
- Email: ohck@ajou.ac.kr
Study Locations
-
-
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Suwon, Korea, Republic of, 443-749
- Recruiting
- Ajou University Hospital
-
Contact:
- chang-kwon oh, M.D.
- Phone Number: 82-10-91657281
- Email: OHCK@ajou.ac.kr
-
Principal Investigator:
- chang kwon oh, M.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged more than 13 years who received a primary kidney transplant
- Subject who is using CNI ± purine synthesis inhibitor + steroid without change within the past 3 months (except the dosage)
- serum creatinine < 2 mg/dL and the variation of serum creatinine < 30% during the past 3 months
- Proteinuria ≤ 1g quantified by 24 hour urine or spot urine protein/creatinine ratio < 1.0
- Subjects who agree with written informed consent
Exclusion Criteria:
- Subjects who received combined non-renal transplantation.
- Subject who received re-transplantation
- Deceased donor without a heartbeat
- Patients with hypersensitivity to Mycophenolate sodium, Mycophenolate acid or Mycophenolate Mofetil or to any of the excipients.
- Patient with HGPRT(Hypoxanthin e-guanine phosphoribosyl-transferase) such as Lesch-Nyhan syndrome and kelley-Seegmiller syndrome.
- HLA-identical living related donor
- ABO blood group incompatible
- HIV, HBsAg, or HCV Ab tests (+)
- Abnormal liver function test (AST or ALT or total bilirubin> upper normal limit x3) ANC < 1,500/μL or WBC < 2,500/μL or platelet < 750,000/μL
- Women who are either pregnant, lactating, planning to become pregnant in the next 12 months.
- Subjects with history of cancer, except successfully treated, localized nonmelanocytic skin cancer Subjects with clinically significant infections within the past 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: steroid withdrawal
The clinical outcome after kidney transplantation, under the immunosuppression of steroid withdrawal starting at 3 months post-transplantation using tacrolimus, mycophenolate mofetil, and basilixumab should be analyzed.
|
Those patients who fulfill the entry criteria enter in this prospective controlled trial of steroid withdrawal starting at three months after transplantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the incidence of biopsy-confirmed acute rejection.
Time Frame: 12 months
|
The primary efficacy variable was the incidence of biopsy-confirmed acute rejection.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
death, graft loss
Time Frame: 12 months
|
The secondary efficacy variables included the cumulative incidence of a composite endpoint of death, and graft loss;
|
12 months
|
adverse events and serious adverse events
Time Frame: 6 months , 12 months
|
The proportion of successfully steroid-withdrawn and steroid-free population at 6 months and at 12 months post-transplantation as well as the safety variables including the incidence of adverse events and serious adverse events, [blood pressure, lipid levels (total cholesterol), BUN (blood urea nitrogen) and blood glucose levels]
|
6 months , 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chang kwon oh, M.D.,Ph. D., Department of surgery, Ajou University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AJIRB-CRO-08-067
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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