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Disorder Related to Renal TransplantationPhase 4NCT01550445

Steroid Withdrawal Immunosuppression After Renal Transplantation

A Phase 4 study testing Prednisolone in people with Disorder Related to Renal Transplantation, run by Ajou University School of Medicine at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 13 years and older
What is being tested?
Prednisolone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
May 2008to Jul 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

chang-kwon Oh, M.D contact

82-10-9165-7281

ohck@ajou.ac.kr

South Korea1 site, 1 recruiting

  • Ajou University Hospital

    Suwon, 443-749

    chang-kwon oh, M.D., 82-10-91657281, OHCK@ajou.ac.kr

    chang kwon oh, M.D

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
Prednisolone
Keywords
Steroid withdrawal, Kidney transplantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrednisoloneDrug

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

Study groups in NCT01550445
Study groupRoleWhat they receive
steroid withdrawalNo interventionThe 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.
Receives: Drug: Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the incidence of biopsy-confirmed acute rejection.

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

    Measured: 12 months

Secondary outcomes (2)

  1. death, graft loss

    The secondary efficacy variables included the cumulative incidence of a composite endpoint of death, and graft loss;

    Measured: 12 months

  2. 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]

    Measured: 6 months , 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2012 (estimated)
  2. Study startMay 2008
  3. Primary completionOct 2009
  4. Study completionJul 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01550445
Sponsor's protocol ID
AJIRB-CRO-08-067
Status last verified
Mar 2012
First submitted
15 Feb 2012
Last updated
12 Mar 2012
Results posted
No
Data monitoring committee
No

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.

    PubMed 22468094

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prednisolone in people with Disorder Related to Renal Transplantation, run by Ajou University School of Medicine at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact chang-kwon Oh, M.D (82-10-9165-7281, ohck@ajou.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the incidence of biopsy-confirmed acute rejection. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01550445, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2012.

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