Chronic Renal FailureNCT02733510
The Impact of Early Protocol Biopsy in Kidney Transplant
An observational study of Chronic Renal Failure, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- methylprednisolone
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Apr 2019
- Phase
- Observational
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: kidney transplantation recipients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center, Organ Transplant Center
Seoul, 135-710
Sung Joo Kim, MD, PhD, 82-2-3410-3476, kmhyj.kim@samsung.com
Jae Berm Park, MD, PhD, 82-2-3410-3647, jbparkmd@gmail.com
About this study
Official title: The Impact of Early Protocol Biopsy in Kidney Transplant Recipients Receiving TAC and MMF; a Prospective Observational Study
- 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
- Conditions
- Chronic Renal Failure
- Being tested
- methylprednisolone
- Keywords
- kidney transplantation, subclinical rejection, steroid pulse therapy
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called steroid pulse therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| subclinical rejection group | patients whose protocol biopsy outcome is subclinical rejection and treat with steroid pulse therapy (methylprednisolone) Receives: Drug: methylprednisolone | |
| No rejection group | patients whose protocol biopsy outcome is normal |
What is being measured
The primary outcome is the main question the study is designed to answer.
biopsy proven acute rejection event
Measured: within 1 year after renal transplantation
incidence of opportunistic infection
Measured: within 1 year after renal transplantation
Secondary outcomes (1)
histologic feature at 1 year protocol biopsy
Measured: 1 year after renal transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Joo Kim, Samsung Medical Center
- Investigators
- Sung Joo Kim, Professor, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733510
- Sponsor's protocol ID
- SMC 2016-02-108-002
- Status last verified
- Apr 2016
- First submitted
- 5 Apr 2016
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
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 9808101Gloor 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 12131699Shishido 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 12660340Choi 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 15888041Miyagi 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 16008588Cosio 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 26274817Nickerson 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 25556171Loupy 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Early Protocol Biopsy in Kidney Transplant Recipients Receiving TAC and MMF; a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02733510
- Acronym / sponsor ID
- SMC 2016-02-108-002
- Conditions
- Chronic Renal Failure
- Keywords
- kidney transplantation, subclinical rejection, steroid pulse therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subclinical rejection group | – | Drug: methylprednisolonepatients whose protocol biopsy outcome is subclinical rejection and treat with steroid pulse therapy (methylprednisolone) |
| No rejection group | – | –patients whose protocol biopsy outcome is normal |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- kidney transplantation recipients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylprednisoloneAlso: steroid pulse therapySteroid 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. | Drug | subclinical rejection group |
Primary outcome
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
1 secondary outcome
histologic feature at 1 year protocol biopsy
Time frame: 1 year after renal transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Results publication: PubMed 9808101Rush 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.
- Results publication: PubMed 12131699Gloor 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.
- Results publication: PubMed 12660340Shishido 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.
- Results publication: PubMed 15888041Choi 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.
- Results publication: PubMed 16008588Miyagi 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.
- Results publication: PubMed 26274817Cosio 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.
- Results publication: PubMed 25556171Nickerson 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.
- Results publication: PubMed 25556173Loupy 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Joo Kim, Professor principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Failure, run by Samsung Medical Center 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 4 inclusion and 8 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 11 Apr 2016. 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.
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 Sung Joo Kim, Professor (82-10-9933-5192, kmhyj111@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biopsy proven acute rejection event (time frame: within 1 year after renal transplantation). The study lists 2 primary outcomes in all. 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 NCT02733510, which also lists 8 linked publications.
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 11 Apr 2016.