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| Name | Class |
|---|---|
| Sociedad Andaluza de Trasplantes de Organos y Tejidos | OTHER |
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Steroids are one of the pillars of immunosuppression for kidney transplant patients but their use is associated with a high rate of complications. Withdrawal of steroids reduces some metabolic and cardiovascular complications, but it may increase the risk of acute rejection. However, little is known about whether steroid withdrawal is associated with the generation of anti-HLA donor-specific antibodies (DSA) and the relation between DSA and clinical and histological data. The aim of this study is to compare the incidence of de novo anti-HLA DSA in stable kidney transplant patients after withdrawing the steroids 3 months after the transplantation as compared with patients who continue with steroids. The hypothesis is that steroid withdrawal will increase the presence of de novo anti-HLA DSA in stable kidney transplant patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroids, tacrolimus and mycophenolate | Active Comparator | Normal treatment arm |
|
| Tacrolimus and mycophenolate | Experimental | Normal treatment for first 90 days, then steroid withdrawal carrying on with the other drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone withdrawal | Drug | Withdrawal of steroids |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cases of Kidney Transplant Patients With DSA | Measurements of DSA at baseline, and at 3, 6, 12, 18 and 24 months | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Score on the Protocol Biopsies in the Two Treatment Groups | Measurement at 24 months according to the Banff classification. The Banff Classification of Allograft Pathology is an international consensus classification for the reporting of biopsies from solid organ transplant. The scale ranges from 0 to 3, 3 being the worst. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Domingo Hernandez, PhD | Carlos Haya Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vall d Hebron Hospital | Barcelona | 08035 | Spain | |||
| Bellvitge Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12392286 | Background | Miller LW. Cardiovascular toxicities of immunosuppressive agents. Am J Transplant. 2002 Oct;2(9):807-18. doi: 10.1034/j.1600-6143.2002.20902.x. | |
| 19852526 | Background | Marcen R. Immunosuppressive drugs in kidney transplantation: impact on patient survival, and incidence of cardiovascular disease, malignancy and infection. Drugs. 2009 Nov 12;69(16):2227-43. doi: 10.2165/11319260-000000000-00000. |
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Of the 230 patients, 125 were not randomized because of: screening failure 74; patient wishes 16; acute rejection 9; graft loss 9; died 3; lost to follow-up 1 and other causes 13. The main causes of screening failure were: creatinine >2 mg/dl and subclinical rejection in the protocol biopsy at the third month. 105 patients were finally included
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| ID | Title | Description |
|---|---|---|
| FG000 | Steroids, Tacrolimus and Mycophenolate | Normal treatment arm Prednisone continuation: Continuation of steroids |
| FG001 | Tacrolimus and Mycophenolate | Normal treatment for first 90 days, then steroid withdrawal carrying on with the other drugs Prednisone withdrawal: Withdrawal of steroids |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2020 |
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| Prednisone continuation |
| Drug |
Continuation of steroids |
|
| Number of Participants With Acute Rejection Lesions |
Patients with acute rejection lesions (including subclinical rejection) at 24 months according to Banff classification |
| 24 months |
| Incidence of Diabetes Mellitus | Incidence of diabetes mellitus after kidney transplant in both groups at 1, 2, 3, 4, 6, 9, 12, 18 and 24 months | 24 months |
| Lipid Profile | Lipid profile after kidney transplant in both groups at 24 months | 24 months |
| Blood Pressure | Blood pressure after kidney transplant in both groups at 24 months | 24 months |
| Renal Function | Renal function after kidney transplant in both groups at 24 months measured according to the creatinine (mg/dL) concentrations | 24 months |
| Assess the Adherence to Immunosuppressive Therapy in the Two Treatment Groups | The Basle scale was used to assess adherence (BAASIS questionnaire) to immunosuppressive therapy. | At 24 months |
| Patient Survival | Patient survival after kidney transplant in both groups | 24 months |
| Graft Survival | Graft survival after kidney transplant in both groups | 24 months |
| Renal Function | Renal function after kidney transplant in both groups at 24 months measured according to the proteinuria (mg/24 h) concentrations | 24 months |
| Barcelona |
| 08907 |
| Spain |
| Carlos Haya Hospital | Málaga | 29010 | Spain |
| Canarias University Hospital | Santa Cruz de Tenerife | 38200 | Spain |
| Dr. Peset Hospital | Valencia | 46017 | Spain |
| 18211506 | Background | Vincenti F, Schena FP, Paraskevas S, Hauser IA, Walker RG, Grinyo J; FREEDOM Study Group. A randomized, multicenter study of steroid avoidance, early steroid withdrawal or standard steroid therapy in kidney transplant recipients. Am J Transplant. 2008 Feb;8(2):307-16. doi: 10.1111/j.1600-6143.2007.02057.x. |
| 19104432 | Background | Arnol M, de Mattos AM, Chung JS, Prather JC, Mittalhenkle A, Norman DJ. Late steroid withdrawal and cardiovascular events in kidney transplant recipients. Transplantation. 2008 Dec 27;86(12):1844-8. doi: 10.1097/TP.0b013e31818ffec0. |
| 23750878 | Background | Opelz G, Dohler B. Association between steroid dosage and death with a functioning graft after kidney transplantation. Am J Transplant. 2013 Aug;13(8):2096-105. doi: 10.1111/ajt.12313. Epub 2013 Jun 10. |
| 15760395 | Background | Opelz G, Dohler B, Laux G; Collaborative Transplant Study. Long-term prospective study of steroid withdrawal in kidney and heart transplant recipients. Am J Transplant. 2005 Apr;5(4 Pt 1):720-8. doi: 10.1111/j.1600-6143.2004.00765.x. |
| 20508858 | Background | Gonzalez-Molina M, Gentil MA, Burgos D, Cabello M, Cobelo C, Bustamante J, Errasti P, Franco A, Hernandez D. Effect of long-term steroid withdrawal in renal transplant recipients: a retrospective cohort study. NDT Plus. 2010 Jun;3(Suppl_2):ii32-ii36. doi: 10.1093/ndtplus/sfq064. |
| 11004223 | Background | Kasiske BL, Chakkera HA, Louis TA, Ma JZ. A meta-analysis of immunosuppression withdrawal trials in renal transplantation. J Am Soc Nephrol. 2000 Oct;11(10):1910-1917. doi: 10.1681/ASN.V11101910. |
| 15599321 | Background | Pascual J, Quereda C, Zamora J, Hernandez D; Spanish Group for Evidence-Based Medicine in Renal Transplantation. Steroid withdrawal in renal transplant patients on triple therapy with a calcineurin inhibitor and mycophenolate mofetil: a meta-analysis of randomized, controlled trials. Transplantation. 2004 Nov 27;78(10):1548-56. doi: 10.1097/01.tp.0000140969.43761.1f. |
| 18936569 | Background | Woodle ES, First MR, Pirsch J, Shihab F, Gaber AO, Van Veldhuisen P; Astellas Corticosteroid Withdrawal Study Group. A prospective, randomized, double-blind, placebo-controlled multicenter trial comparing early (7 day) corticosteroid cessation versus long-term, low-dose corticosteroid therapy. Ann Surg. 2008 Oct;248(4):564-77. doi: 10.1097/SLA.0b013e318187d1da. |
| 14961999 | Background | Terasaki PI, Ozawa M. Predicting kidney graft failure by HLA antibodies: a prospective trial. Am J Transplant. 2004 Mar;4(3):438-43. doi: 10.1111/j.1600-6143.2004.00360.x. |
| 22429309 | Background | Wiebe C, Gibson IW, Blydt-Hansen TD, Karpinski M, Ho J, Storsley LJ, Goldberg A, Birk PE, Rush DN, Nickerson PW. Evolution and clinical pathologic correlations of de novo donor-specific HLA antibody post kidney transplant. Am J Transplant. 2012 May;12(5):1157-67. doi: 10.1111/j.1600-6143.2012.04013.x. Epub 2012 Mar 19. |
| 20098280 | Background | Gill JS, Landsberg D, Johnston O, Shapiro RJ, Magil AB, Wu V, Tinckam K, Keown P. Screening for de novo anti-human leukocyte antigen antibodies in nonsensitized kidney transplant recipients does not predict acute rejection. Transplantation. 2010 Jan 27;89(2):178-84. doi: 10.1097/TP.0b013e3181c3503e. |
| 21906255 | Background | Cantarovich D, De Amicis S, Akl A, Devys A, Vistoli F, Karam G, Soulillou JP. Posttransplant donor-specific anti-HLA antibodies negatively impact pancreas transplantation outcome. Am J Transplant. 2011 Dec;11(12):2737-46. doi: 10.1111/j.1600-6143.2011.03729.x. Epub 2011 Sep 11. |
| 22592887 | Background | Hoshino J, Kaneku H, Everly MJ, Greenland S, Terasaki PI. Using donor-specific antibodies to monitor the need for immunosuppression. Transplantation. 2012 Jun 15;93(11):1173-8. doi: 10.1097/TP.0b013e31824f3d7c. |
| 12698094 | Background | Worthington JE, Martin S, Al-Husseini DM, Dyer PA, Johnson RW. Posttransplantation production of donor HLA-specific antibodies as a predictor of renal transplant outcome. Transplantation. 2003 Apr 15;75(7):1034-40. doi: 10.1097/01.TP.0000055833.65192.3B. |
| 17391129 | Background | Mao Q, Terasaki PI, Cai J, Briley K, Catrou P, Haisch C, Rebellato L. Extremely high association between appearance of HLA antibodies and failure of kidney grafts in a five-year longitudinal study. Am J Transplant. 2007 Apr;7(4):864-71. doi: 10.1111/j.1600-6143.2006.01711.x. |
| 16539631 | Background | Moreso F, Ibernon M, Goma M, Carrera M, Fulladosa X, Hueso M, Gil-Vernet S, Cruzado JM, Torras J, Grinyo JM, Seron D. Subclinical rejection associated with chronic allograft nephropathy in protocol biopsies as a risk factor for late graft loss. Am J Transplant. 2006 Apr;6(4):747-52. doi: 10.1111/j.1600-6143.2005.01230.x. |
| 18773960 | Background | Anil Kumar MS, Irfan Saeed M, Ranganna K, Malat G, Sustento-Reodica N, Kumar AM, Meyers WC. Comparison of four different immunosuppression protocols without long-term steroid therapy in kidney recipients monitored by surveillance biopsy: five-year outcomes. Transpl Immunol. 2008 Nov;20(1-2):32-42. doi: 10.1016/j.trim.2008.08.005. Epub 2008 Sep 4. |
| 34067039 | Derived | Hernandez D, Alonso-Titos J, Vazquez T, Leon M, Caballero A, Cobo MA, Sola E, Lopez V, Ruiz-Esteban P, Cruzado JM, Sellares J, Moreso F, Manonelles A, Torio A, Cabello M, Delgado-Burgos J, Casas C, Gutierrez E, Jironda C, Kanter J, Seron D, Torres A. Clinical Relevance of Corticosteroid Withdrawal on Graft Histological Lesions in Low-Immunological-Risk Kidney Transplant Patients. J Clin Med. 2021 May 7;10(9):2005. doi: 10.3390/jcm10092005. |
| 33947168 | Derived | Hernandez D, Vazquez T, Alonso-Titos J, Leon M, Caballero A, Cobo MA, Sola E, Lopez V, Ruiz-Esteban P, Cruzado JM, Sellares J, Moreso F, Manonelles A, Torio A, Cabello M, Delgado-Burgos J, Casas C, Gutierrez E, Jironda C, Kanter J, Seron D, Torres A. Impact of HLA Mismatching on Early Subclinical Inflammation in Low-Immunological-Risk Kidney Transplant Recipients. J Clin Med. 2021 Apr 29;10(9):1934. doi: 10.3390/jcm10091934. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Steroids, Tacrolimus and Mycophenolate | Normal treatment arm Prednisone continuation: Continuation of steroids |
| BG001 | Tacrolimus and Mycophenolate | Normal treatment for first 90 days, then steroid withdrawal carrying on with the other drugs Prednisone withdrawal: Withdrawal of steroids |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cases of Kidney Transplant Patients With DSA | Measurements of DSA at baseline, and at 3, 6, 12, 18 and 24 months | Posted | Count of Participants | Participants | 24 months |
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| Secondary | Mean Score on the Protocol Biopsies in the Two Treatment Groups | Measurement at 24 months according to the Banff classification. The Banff Classification of Allograft Pathology is an international consensus classification for the reporting of biopsies from solid organ transplant. The scale ranges from 0 to 3, 3 being the worst. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
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| Secondary | Number of Participants With Acute Rejection Lesions | Patients with acute rejection lesions (including subclinical rejection) at 24 months according to Banff classification | Posted | Count of Participants | Participants | 24 months |
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| Secondary | Incidence of Diabetes Mellitus | Incidence of diabetes mellitus after kidney transplant in both groups at 1, 2, 3, 4, 6, 9, 12, 18 and 24 months | Posted | Count of Participants | Participants | 24 months |
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| Secondary | Lipid Profile | Lipid profile after kidney transplant in both groups at 24 months | Posted | Mean | Standard Deviation | mg/dl | 24 months |
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| Secondary | Blood Pressure | Blood pressure after kidney transplant in both groups at 24 months | Posted | Mean | Standard Deviation | mmHg | 24 months |
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| Secondary | Renal Function | Renal function after kidney transplant in both groups at 24 months measured according to the creatinine (mg/dL) concentrations | Posted | Mean | Standard Deviation | mg/dl | 24 months |
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| Secondary | Assess the Adherence to Immunosuppressive Therapy in the Two Treatment Groups | The Basle scale was used to assess adherence (BAASIS questionnaire) to immunosuppressive therapy. | Posted | Count of Participants | Participants | At 24 months |
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| Secondary | Patient Survival | Patient survival after kidney transplant in both groups | Posted | Count of Participants | Participants | 24 months |
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| Secondary | Graft Survival | Graft survival after kidney transplant in both groups | Posted | Count of Participants | Participants | 24 months |
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| Secondary | Renal Function | Renal function after kidney transplant in both groups at 24 months measured according to the proteinuria (mg/24 h) concentrations | Posted | Mean | Standard Deviation | mg/24h | 24 months |
|
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24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Steroids, Tacrolimus and Mycophenolate | Normal treatment arm Prednisone continuation: Continuation of steroids | 0 | 52 | 10 | 52 | 0 | 52 |
| EG001 | Tacrolimus and Mycophenolate | Normal treatment for first 90 days, then steroid withdrawal carrying on with the other drugs Prednisone withdrawal: Withdrawal of steroids | 0 | 53 | 15 | 53 | 0 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Renal and urinary disorders | Systematic Assessment | Infection requiring attention |
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| Cardiovascular Disease | Cardiac disorders | Systematic Assessment |
| ||
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Domingo Hernandez | Hospital Regional Universitario de Málaga | 951291174 | domingohernandez@gmail.com |
| Jan 10, 2020 |
| Prot_SAP_000.pdf |
| >=65 years |
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| Male |
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| Black |
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| North African |
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| Hispanic |
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