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Status unknownNCT02733510Updated Apr 11, 2016

The Impact of Early Protocol Biopsy in Kidney Transplant

An observational study in Chronic Renal Failure, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-04-11.

Sponsored by Samsung Medical Center · Observational

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
19 Years to 70 Years
Sex
All
01

Study summary

  • The purpose of this study is evaluating the impact of steroid pulse therapy (SPT) on SCR revealed on PB in KT recipients maintained on TAC/MMF and corticosteroid.
  • In our institution, since routine protocol biopsies are performed at 2 weeks, 1 year, and 2 years after renal transplantation, it is practically difficult that graft survival is used as an endpoint for randomized controlled trials.
  • From a meta-analysis for 31 observational studies , acute rejection was associated with an increased risk of graft loss risk ratios ranged from 1.2 - 10.5. Furthermore, chronic allograft nephropathy and graft survival is strongly correlated with acute rejection episode during the first year after renal transplantation.
  • Therefore, the aim of this study is to investigate the effect of early steroid pulse therapy for the reduction of acute rejection episode during the first year after KT in the patients who will show subclinical changes at 2-week protocol biopsy.
  • The histological feature at 1 year PB, graft function (represented by serum creatinine level and eGFR) during the 1st year of KT were compared between SCR group and non-SCR group.
  • Additional benefits including early detection of polioma BK virus associated nephritis (BKVAN) and relapsed underlying disease are also evaluated.
Read the detailed description
  • All recipients will receive induction therapy with basiliximab or rATG and triple maintenance immunosuppression with TAC/MMF and corticosteroid.
  • PB at 2 weeks and 1 year after transplantation will be performed using an 18-gauge needle under ultrasound guidance.
  • Patients who will get PB can be the candidate of this study.
  • Methylprednisolone 0.5 g daily for 3 days will be administered in patients with SCR.
  • Information of enrolled patient including age, sex, height, body weight, serum creatinine level, modality of dialysis, duration of dialysis, panel reactive antibody, donor specific antibody, HLA mismatch, ABO incompatibility and history of previous transplantation will be collected. These data will be safely controlled by the person in charge. Patient name will be changed in to initials and registration number of hospital will be changed into new registration number of this study.
  • laboratory tests including WBC, BUN, creatinine, FK level, MPA level, CMV virus DNA load, BK virus DNA load, urine nitrate, urine leukocyte esterase, urine BK virus DNA load, urine culture and chest X-ray will be checked on 14th post-operative day and every month until 1year after KT.
  • Enrolled patients will be followed for 1 year and routinely undergo 1-year protocol biopsy.
  • Within 1 year follow up period, clinical biopsy is performed when recipients' serum creatinine level raised more than 25% of baseline level.
  • The primary end point
  • Biopsy proven acute rejection event within 1 year after renal transplantation
  • Histologic feature including persistent SCR (the presence of SCR at both 2-week and 1-year protocol biopsy), chronic nephropathy at 1-year protocol biopsy.
  • Graft kidney function estimated by serum creatinine level and eGFR
  • The incidence of opportunistic infection including pneumonia, urinary tract infection, tuberculosis, fungal infection, and viral infections (such as cytomegalo, polyoma, and parvo-virus) within 1 year
  • Secondary end points include effect of early detection of polioma BK virus associated nephritis (BKVAN) and relapsed underlying disease
02

Conditions studied

  • Chronic Renal Failure

Keywords

  • kidney transplantation
  • subclinical rejection
  • steroid pulse therapy
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's planned enrollment of 200 is above the median of 120 across 431 observational studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

kidney transplantation recipients

Inclusion criteria

  • Age 19 - 70 years.
  • The patients who underwent renal transplantation.

  • The patients who will show rejection in 2-week protocol biopsy with stable graft function will be included in this study.

    • Stable function is defined as serum creatinine ≤1.5 mg/dl and ≤15% increase in serum creatinine in the 2 weeks before biopsy.

Exclusion criteria

Exclusion Criteria:

  • The patients who had clinical uremic symptom within 2 weeks after kidney transplantation..
  • The patients who had elevated serum creatinine level more than 1.5mg/dl or 15% compared to previous result.
  • The patients' age under 19 years or over 70 years.
  • The patients who underwent preoperative desensitization.
  • The patients who had multiple organ transplantation.
  • The patients who showed an allergic reaction to steroid.
  • The patients who had psychologic disease (eg. depression) or history of psychologic medication.
  • The patients who did not agree with a consent form.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • subclinical rejection group

    patients whose protocol biopsy outcome is subclinical rejection and treat with steroid pulse therapy (methylprednisolone)

    Drug: methylprednisolone

  • No rejection group

    patients whose protocol biopsy outcome is normal

Interventions

  • Drugmethylprednisolone

    Steroid pulse therapy : Methylprednisolone 0.5 g daily for 3 days, followed by a tapered dose of 60 mg per day for a period of five days.

    Also known as: steroid pulse therapy

06

What researchers measure

Primary outcomes

  1. biopsy proven acute rejection event

    Time frame: within 1 year after renal transplantation

  2. incidence of opportunistic infection

    Time frame: within 1 year after renal transplantation

Secondary outcomes

  1. histologic feature at 1 year protocol biopsy

    Time frame: 1 year after renal transplantation

07

Study locations

1 of 1 sites recruiting
  • Samsung Medical Center, Organ Transplant Center
    Seoul, 135-710, Korea, Republic of
    • Sung Joo Kim, MD, PhD · Contact · kmhyj.kim@samsung.com · 82-2-3410-3476
    • Jae Berm Park, MD, PhD · Contact · jbparkmd@gmail.com · 82-2-3410-3647
    • Sung Joo Kim, MD, PhD · Principal investigator
    • Jae Berm Park, MD, PhD · Sub investigator
    Recruiting
08

References and documents

Publications

  • Rush D, Nickerson P, Gough J, McKenna R, Grimm P, Cheang M, Trpkov K, Solez K, Jeffery J. Beneficial effects of treatment of early subclinical rejection: a randomized study. J Am Soc Nephrol. 1998 Nov;9(11):2129-34. doi: 10.1681/ASN.V9112129. PubMed 9808101 ↗
  • Gloor JM, Cohen AJ, Lager DJ, Grande JP, Fidler ME, Velosa JA, Larson TS, Schwab TR, Griffin MD, Prieto M, Nyberg SL, Sterioff S, Kremers WK, Stegall MD. Subclinical rejection in tacrolimus-treated renal transplant recipients. Transplantation. 2002 Jun 27;73(12):1965-8. doi: 10.1097/00007890-200206270-00023. PubMed 12131699 ↗
  • Shishido S, Asanuma H, Nakai H, Mori Y, Satoh H, Kamimaki I, Hataya H, Ikeda M, Honda M, Hasegawa A. The impact of repeated subclinical acute rejection on the progression of chronic allograft nephropathy. J Am Soc Nephrol. 2003 Apr;14(4):1046-52. doi: 10.1097/01.asn.0000056189.02819.32. PubMed 12660340 ↗
  • Choi BS, Shin MJ, Shin SJ, Kim YS, Choi YJ, Kim YS, Moon IS, Kim SY, Koh YB, Bang BK, Yang CW. Clinical significance of an early protocol biopsy in living-donor renal transplantation: ten-year experience at a single center. Am J Transplant. 2005 Jun;5(6):1354-60. doi: 10.1111/j.1600-6143.2005.00830.x. PubMed 15888041 ↗
  • Miyagi M, Ishikawa Y, Mizuiri S, Aikawa A, Ohara T, Hasegawa A. Significance of subclinical rejection in early renal allograft biopsies for chronic allograft dysfunction. Clin Transplant. 2005 Aug;19(4):456-65. doi: 10.1111/j.1399-0012.2005.00303.x. PubMed 16008588 ↗
  • Cosio FG, El Ters M, Cornell LD, Schinstock CA, Stegall MD. Changing Kidney Allograft Histology Early Posttransplant: Prognostic Implications of 1-Year Protocol Biopsies. Am J Transplant. 2016 Jan;16(1):194-203. doi: 10.1111/ajt.13423. Epub 2015 Aug 14. PubMed 26274817 ↗
  • Nickerson PW, Rush DN. Begin at the Beginning to Prevent the End. J Am Soc Nephrol. 2015 Jul;26(7):1483-5. doi: 10.1681/ASN.2014111115. Epub 2015 Jan 2. No abstract available. PubMed 25556171 ↗
  • Loupy A, Vernerey D, Tinel C, Aubert O, Duong van Huyen JP, Rabant M, Verine J, Nochy D, Empana JP, Martinez F, Glotz D, Jouven X, Legendre C, Lefaucheur C. Subclinical Rejection Phenotypes at 1 Year Post-Transplant and Outcome of Kidney Allografts. J Am Soc Nephrol. 2015 Jul;26(7):1721-31. doi: 10.1681/ASN.2014040399. Epub 2015 Jan 2. PubMed 25556173 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02733510
Lead sponsor
Samsung Medical Center
Responsible party
Sung-Joo Kim (Professor, Samsung Medical Center) — Principal investigator
First posted
Apr 11, 2016
Start date
Apr 2016
Primary completion
Apr 2019 (estimated)
Completion
Apr 2019 (estimated)
Last update
Apr 11, 2016

Study contacts

Sung Joo Kim, Professor
Contact
kmhyj111@gmail.com
82-10-9933-5192
Sung Joo Kim, Professor
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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