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
- 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|
- 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
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
subclinical rejection group
patients whose protocol biopsy outcome is subclinical rejection and treat with steroid pulse therapy (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
- biopsy proven acute rejection event [ Time Frame: within 1 year after renal transplantation ]
- incidence of opportunistic infection [ Time Frame: within 1 year after renal transplantation ]
- histologic feature at 1 year protocol biopsy [ Time Frame: 1 year after renal transplantation ]
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
|Contact: Sung Joo Kim, Professoremail@example.com|
|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 firstname.lastname@example.org|
|Contact: Jae Berm Park, MD, PhD 82-2-3410-3647 email@example.com|
|Principal Investigator: Sung Joo Kim, MD, PhD|
|Sub-Investigator: Jae Berm Park, MD, PhD|
|Principal Investigator:||Sung Joo Kim, Professor||Samsung Medical Center|