Steroid Withdrawal Immunosuppression After Renal Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Ajou University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Chang kwon oh, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01550445
First received: February 15, 2012
Last updated: March 7, 2012
Last verified: March 2012

February 15, 2012
March 7, 2012
May 2008
October 2009   (final data collection date for primary outcome measure)
the incidence of biopsy-confirmed acute rejection. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The primary efficacy variable was the incidence of biopsy-confirmed acute rejection.
Same as current
Complete list of historical versions of study NCT01550445 on ClinicalTrials.gov Archive Site
  • death, graft loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The secondary efficacy variables included the cumulative incidence of a composite endpoint of death, and graft loss;
  • adverse events and serious adverse events [ Time Frame: 6 months , 12 months ] [ Designated as safety issue: No ]
    The proportion of successfully steroid-withdrawn and steroid-free population at 6 months and at 12 months post-transplantation as well as the safety variables including the incidence of adverse events and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]
Same as current
Not Provided
Not Provided
 
Steroid Withdrawal Immunosuppression After Renal Transplantation
Prospective Controlled Protocol for 3 Months Steroid Withdrawal With Tacrolimus, Basiliximab, and Mycophenolate Mofetil in Renal Transplant Recipients

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Disorder Related to Renal Transplantation
Drug: Prednisolone
Those patients who fulfill the entry criteria enter in this prospective controlled trial of steroid withdrawal starting at three months after transplantation
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.
Intervention: Drug: Prednisolone
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
July 2012
October 2009   (final data collection date for primary outcome measure)

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.
Both
13 Years and older
No
Contact: chang-kwon Oh, M.D 82-10-9165-7281 ohck@ajou.ac.kr
Korea, Republic of
 
NCT01550445
AJIRB-CRO-08-067
No
Chang kwon oh, Ajou University School of Medicine
Ajou University School of Medicine
Not Provided
Principal Investigator: Chang kwon oh, M.D.,Ph. D. Department of surgery, Ajou University School of Medicine
Ajou University School of Medicine
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP