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Steroid Withdrawal Immunosuppression After Renal Transplantation

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ClinicalTrials.gov Identifier: NCT01550445
Recruitment Status : Unknown
Verified March 2012 by Chang kwon oh, Ajou University School of Medicine.
Recruitment status was:  Recruiting
First Posted : March 12, 2012
Last Update Posted : March 12, 2012
Sponsor:
Information provided by (Responsible Party):
Chang kwon oh, Ajou University School of Medicine

Tracking Information
First Submitted Date  ICMJE February 15, 2012
First Posted Date  ICMJE March 12, 2012
Last Update Posted Date March 12, 2012
Study Start Date  ICMJE May 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
the incidence of biopsy-confirmed acute rejection. [ Time Frame: 12 months ]
The primary efficacy variable was the incidence of biopsy-confirmed acute rejection.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
  • death, graft loss [ Time Frame: 12 months ]
    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 ]
    The proportion of successfully steroid-withdrawn and steroid-free population at 6 months and at 12 months post-transplantation as well as the safety variables including the incidence of adverse events and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]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Steroid Withdrawal Immunosuppression After Renal Transplantation
Official Title  ICMJE Prospective Controlled Protocol for 3 Months Steroid Withdrawal With Tacrolimus, Basiliximab, and Mycophenolate Mofetil in Renal Transplant Recipients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Disorder Related to Renal Transplantation
Intervention  ICMJE Drug: Prednisolone
Those patients who fulfill the entry criteria enter in this prospective controlled trial of steroid withdrawal starting at three months after transplantation
Study Arms  ICMJE 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 7, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2012
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01550445
Other Study ID Numbers  ICMJE AJIRB-CRO-08-067
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chang kwon oh, Ajou University School of Medicine
Study Sponsor  ICMJE Ajou University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chang kwon oh, M.D.,Ph. D. Department of surgery, Ajou University School of Medicine
PRS Account Ajou University School of Medicine
Verification Date March 2012

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