NCT01550445

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 12, 2012

Status Verified

March 1, 2012

Enrollment Period

1.4 years

First QC Date

February 15, 2012

Last Update Submit

March 7, 2012

Conditions

Disorder Related to Renal Transplantation

Keywords

Steroid withdrawal, Kidney transplantation

Outcome Measures

Primary Outcomes (1)

  • the incidence of biopsy-confirmed acute rejection.

    The primary efficacy variable was the incidence of biopsy-confirmed acute rejection.

    12 months

Secondary Outcomes (2)

  • death, graft loss

    12 months

  • adverse events and serious adverse events

    6 months , 12 months

Study Arms (1)

steroid withdrawal

NO INTERVENTION

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

Interventions

PrednisoloneDRUG

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

steroid withdrawal

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, 443-749, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22468094DERIVED

MeSH Terms

Interventions

Prednisolone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Chang kwon oh, M.D.,Ph. D.

    Department of surgery, Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

chang-kwon Oh, M.D

CONTACT

82-10-9165-7281ohck@ajou.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Surgery

Study Record Dates

First Submitted

February 15, 2012

First Posted

March 12, 2012

Study Start

May 1, 2008

Primary Completion

October 1, 2009

Study Completion

July 1, 2012

Last Updated

March 12, 2012

Record last verified: 2012-03

Locations

KR(1)