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The Impact of Early Protocol Biopsy in Kidney Transplant

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ClinicalTrials.gov Identifier: NCT02733510
Recruitment Status : Unknown
Verified April 2016 by Sung-Joo Kim, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : April 11, 2016
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):
Sung-Joo Kim, Samsung Medical Center

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.

Condition or disease Intervention/treatment
Chronic Renal Failure Drug: methylprednisolone

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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Early Protocol Biopsy in Kidney Transplant Recipients Receiving TAC and MMF; a Prospective Observational Study
Study Start Date : April 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019


Group/Cohort Intervention/treatment
subclinical rejection group
patients whose protocol biopsy outcome is subclinical rejection and treat with steroid pulse therapy (methylprednisolone)
Drug: methylprednisolone
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.
Other Name: steroid pulse therapy

No rejection group
patients whose protocol biopsy outcome is normal



Primary Outcome Measures :
  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 Outcome Measures :
  1. histologic feature at 1 year protocol biopsy [ Time Frame: 1 year after renal transplantation ]


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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
kidney transplantation recipients
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733510


Contacts
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Contact: Sung Joo Kim, Professor 82-10-9933-5192 kmhyj111@gmail.com

Locations
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Korea, Republic of
Samsung Medical Center, Organ Transplant Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Sung Joo Kim, MD, PhD    82-2-3410-3476    kmhyj.kim@samsung.com   
Contact: Jae Berm Park, MD, PhD    82-2-3410-3647    jbparkmd@gmail.com   
Principal Investigator: Sung Joo Kim, MD, PhD         
Sub-Investigator: Jae Berm Park, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Sung Joo Kim, Professor Samsung Medical Center
Publications of Results:

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Responsible Party: Sung-Joo Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02733510    
Other Study ID Numbers: SMC 2016-02-108-002
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Sung-Joo Kim, Samsung Medical Center:
kidney transplantation
subclinical rejection
steroid pulse therapy
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents