The Impact of Early Protocol Biopsy in Kidney Transplant

NCT02733510 | Unknown DMC

• 1 other identifier: SMC 2016-02-108-002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Renal Failure

Keywords

kidney transplantation; subclinical rejection; steroid pulse therapy

Outcome Measures

Primary Outcomes (2)

• biopsy proven acute rejection event

  within 1 year after renal transplantation

• incidence of opportunistic infection

  within 1 year after renal transplantation

Secondary Outcomes (1)

• histologic feature at 1 year protocol biopsy

  1 year after renal transplantation

Study Arms (2)

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

methylprednisolone DRUG

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

subclinical rejection group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

kidney transplantation recipients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center, Organ Transplant Center

Seoul, 135-710, South Korea

RECRUITING

Related Publications (8)

• 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.

  PMID: 9808101 RESULT

• 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.

  PMID: 12131699 RESULT

• 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.

  PMID: 12660340 RESULT

• 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.

  PMID: 15888041 RESULT

• 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.

  PMID: 16008588 RESULT

• 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.

  PMID: 26274817 RESULT

• 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.

  PMID: 25556171 RESULT

• 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.

  PMID: 25556173 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sung Joo Kim, Professor

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Joo Kim, Professor

CONTACT

82-10-9933-5192; kmhyj111@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 11, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 11, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)