Chronic Renal Failure Clinical Trial
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | April 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years to 70 Years |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center, Organ Transplant Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
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): — View Citation
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. — View Citation
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 — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | biopsy proven acute rejection event | within 1 year after renal transplantation | No | |
Primary | incidence of opportunistic infection | within 1 year after renal transplantation | No | |
Secondary | histologic feature at 1 year protocol biopsy | 1 year after renal transplantation | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02565459 -
MSC and Kidney Transplant Tolerance (Phase A)
|
Phase 1 | |
Recruiting |
NCT01876017 -
Safety and Efficacy of BMMNC in Patients With Chronic Renal Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT02356419 -
rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics
|
Phase 1 | |
Withdrawn |
NCT03019159 -
Assessment of a Follow-up With Tele-consulting for Patients With Renal Failure Under Peritoneal Dialysis
|
N/A | |
Completed |
NCT02047006 -
Dose-finding of Rivaroxaban in Hemodialysis
|
Phase 4 | |
Completed |
NCT01617824 -
Rapid Effects Linagliptin on Monocyte Polarization and Endothelial Progenitor Cells in Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT00828776 -
Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal Failure
|
Phase 2/Phase 3 | |
Completed |
NCT00597753 -
Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
|
Phase 3 | |
Completed |
NCT00379899 -
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
|
Phase 4 | |
Terminated |
NCT00372489 -
Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD
|
Phase 2 | |
Completed |
NCT00228436 -
Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients
|
Phase 2 | |
Completed |
NCT03772171 -
Estimate for Dietary Intakes and Hemodialysis Patients
|
||
Recruiting |
NCT02586402 -
Safety & Efficacy of Pegolsihematide for Treatment of Anemia in Participants on Dialysis
|
Phase 2 | |
Completed |
NCT01879618 -
Use Of Fragmin In Hemodialysis
|
Phase 3 | |
Not yet recruiting |
NCT01346215 -
Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure
|
Phase 3 | |
Completed |
NCT01220843 -
FGF23 Reduction : Efficacy of a New Phosphate Binder in CHronic Kidney Disease
|
Phase 3 | |
Completed |
NCT01111630 -
Study of Erythropoietin (EPO) Administration Schedule
|
Phase 4 | |
Completed |
NCT00742716 -
Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
|
Phase 2 | |
Completed |
NCT00597584 -
Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
|
Phase 3 | |
Completed |
NCT00598273 -
Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
|
Phase 3 |