Steroid Withdrawal Immunosuppression After Renal Transplantation

Disorder Related to Renal Transplantation Clinical Trial

Official title:

Prospective Controlled Protocol for 3 Months Steroid Withdrawal With Tacrolimus, Basiliximab, and Mycophenolate Mofetil in Renal Transplant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01550445
• Other study ID #: AJIRB-CRO-08-067
• Status: Recruiting
• Phase: Phase 4
• First received: February 15, 2012
• Last updated: March 7, 2012
• Start date: May 2008
• Est. completion date: July 2012

Study information

• Verified date: March 2012
• Source: Ajou University School of Medicine
• Contact: chang-kwon Oh, M.D
• Phone: 82-10-9165-7281
• Email: ohck[@]ajou.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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For the patients who enter into the protocol, prednisolone would be slowly withdrawn by 2.5 mg in every two weeks until 8 weeks after entering the protocol (5 months post-transplantation).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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorder Related to Renal Transplantation

Intervention

Drug:
• Prednisolone
Those patients who fulfill the entry criteria enter in this prospective controlled trial of steroid withdrawal starting at three months after transplantation

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of biopsy-confirmed acute rejection.	The primary efficacy variable was the incidence of biopsy-confirmed acute rejection.	12 months	No
Secondary	death, graft loss	The secondary efficacy variables included the cumulative incidence of a composite endpoint of death, and graft loss;	12 months	No
Secondary	adverse events and serious adverse events	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	No