Steroid Withdrawal Immunosuppression After Renal Transplantation

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ajou University School of Medicine
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Tacrolimus

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.