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
  Purpose

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.


Condition Intervention Phase
Disorder Related to Renal Transplantation
Drug: Prednisolone
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Controlled Protocol for 3 Months Steroid Withdrawal With Tacrolimus, Basiliximab, and Mycophenolate Mofetil in Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Ajou University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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    The proportion of successfully steroid-withdrawn and steroid-free population at 6 months and at 12 months post-transplantation as well as the safety variables including the incidence of adverse events and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]


Estimated Enrollment: 30
Study Start Date: May 2008
Estimated Study Completion Date: July 2012
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Prednisolone
Those patients who fulfill the entry criteria enter in this prospective controlled trial of steroid withdrawal starting at 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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550445

Contacts
Contact: chang-kwon Oh, M.D 82-10-9165-7281 ohck@ajou.ac.kr

Locations
Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Korea, Republic of, 443-749
Contact: chang-kwon oh, M.D.    82-10-91657281    OHCK@ajou.ac.kr   
Principal Investigator: chang kwon oh, M.D         
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Principal Investigator: Chang kwon oh, M.D.,Ph. D. Department of surgery, Ajou University School of Medicine
  More Information

No publications provided by Ajou University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chang kwon oh, Professor, Department of Surgery, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01550445     History of Changes
Other Study ID Numbers: AJIRB-CRO-08-067
Study First Received: February 15, 2012
Last Updated: March 7, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Ajou University School of Medicine:
Steroid withdrawal, Kidney transplantation

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014