Clinical trial NCT01550445: Steroid Withdrawal Immunosuppression After Renal Transplantation
Official title: Prospective Controlled Protocol for 3 Months Steroid Withdrawal With Tacrolimus, Basiliximab, and Mycophenolate Mofetil in Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Disorder Related to Renal Transplantation
Keywords: Steroid withdrawal, Kidney transplantation
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2012-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators analyze the clinical outcome of steroid withdrawal protocol starting at 3 months after kidney transplantation using tacrolimus, Mycophenolate Mofetil (MMF), and basiliximab. This study is an open-label, prospective, controlled clinical trial in a single center. Those patients who fulfill the entry criteria could enter in this prospective controlled trial of steroid withdrawal three months after transplantation.

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For the patients who enter into the protocol, prednisolone would be slowly withdrawn by 2.5 mg in every two weeks until 8 weeks after entering the protocol (5 months post-transplantation).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.

Eligibility criteria: 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.

Primary outcomes:
measure: the incidence of biopsy-confirmed acute rejection.
timeFrame: 12 months
Secondary outcomes:
measure: death, graft loss
timeFrame: 12 months
measure: adverse events and serious adverse events
timeFrame: 6 months , 12 months
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Department of surgery, Ajou University School of Medicine
name: Chang kwon oh, M.D.,Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oh CK, Kim SJ, Kim JH, Lee JH. Prospective controlled protocol for three months steroid withdrawal with tacrolimus, basiliximab, and mycophenolate mofetil in renal transplant recipients. J Korean Med Sci. 2012 Apr;27(4):337-42. doi: 10.3346/jkms.2012.27.4.337. Epub 2012 Mar 21.