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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
| Hoffmann-La Roche | INDUSTRY |
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Over the last 40 years, corticosteroids (steroids) have been an important part of drug regimens used to prevent organ rejection and to maintain the immune health of individuals who have received organ transplants. Unfortunately, the negative physical effects of steroids can be severe, especially in children. The purpose of this study is to determine the safety and effectiveness of a steroid-free treatment regimen for children and adolescents who have received kidney (renal) transplants.
Corticosteroids (steroids) have been a cornerstone of immunosuppressive therapy for kidney (renal) transplantation for over 40 years. However, poor growth and bone loss caused by the use of steroids are devastating to pediatric kidney recipients. The negative physical implications of steroid use also greatly impacts patients' compliance to their prescribed steroid-containing regimens.
The development of a steroid-free regimen for post-transplant pediatric patients is sorely needed. This study will evaluate the safety and efficacy of a steroid-free based treatment regimen in children and adolescents who have received kidney transplants, compared to a standard of care steroid-based regimen. Participants in this study will be pediatric patients with end-stage kidney disease who will undergo kidney transplantation at the start of the study.
Patients will participate in this study for 3 years. Participants will be randomized (1:1) to one of two groups. The study includes 23 study visits over 3 years. A physical exam, medication history, adverse events reporting, blood pressure readings, growth assessment, and blood collection will occur at most visits. At the time of transplantation, participants will have a kidney biopsy. Participants will also undergo cataract screening within 4 months of transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid-Based Immunosuppression | Active Comparator | Subjects will receive prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg) and proceed with a prednisone taper according to the trial's protocol. |
|
| Steroid-Free Immunosuppression | Experimental | Subjects will receive extended daclizumab induction until the sixth month post-transplant (2 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclizumab | Drug | Steroid-Based Immunosuppression(Prednisone) arm: 1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8 (e.g., standard dose of daclizumab induction until the second month post-transplant) Steroid-Free Immunosuppression (Extended daclizumab induction) arm: 2 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11, and months 4, 5, and 6 (e.g., extended daclizumab induction until the sixth month post-transplant) |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation | Standardized Z-scores were computed following a formula using an age- and gender-specific calculation provided by the NHANES III 2000 Growth Data set. The Z-score system expresses anthropometric values of height as several standard deviations (SDs) below (e.g., a negative value) or above (a positive value) the reference mean or median value. In this study the measure was used to test whether there is a difference in the change in height between the treatment groups: Steroid-Based versus Steroid-Free | One year post kidney transplantation procedure |
| Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation | Biopsy-proven acute renal (kidney) rejection [1, 2].
| Up to one year post kidney transplantation procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Minnie Sarwal, MD, PhD | California Pacific Medical Center | Study Chair |
| Oscar Salvatierra, MD | Pediatric Kidney Transplant Program, Stanford University Medical Center, Stanford Hospital and Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama - Pediatric Nephrology | Birmingham | Alabama | 35233 | United States | ||
| Maxine Dunitz Children's Health Center Cedars-Sinai |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11571448 | Background | Cole E, Landsberg D, Russell D, Zaltzman J, Kiberd B, Caravaggio C, Vasquez AR, Halloran P. A pilot study of steroid-free immunosuppression in the prevention of acute rejection in renal allograft recipients. Transplantation. 2001 Sep 15;72(5):845-50. doi: 10.1097/00007890-200109150-00018. | |
| 14627912 | Background |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| SDY132 | Individual Participant Data Set | View IPD |
Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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Twelve pediatric kidney transplantation centers in the United States enrolled 130 subjects (less than 21 years of age) who received a primary kidney transplant from a deceased or living donor. Subject enrollment occurred between March 2004 and July 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Steroid-Free Immunosuppression | Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Mycophenolate mofetil (MMF) | Drug | Intravenous MMF was dosed at 1200 mg/m^2/day in two divided doses preoperatively and for the first 48 hours postoperatively. Oral MMF was dosed at 600 to 900 mg/m^2/day in two divided doses; the dose range allowed for dose titration according to tolerability and side effects of MMF. This regimen was used in both arms. |
|
|
| Prednisone | Drug | Administered as 10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40 kg and 1.5 mg/kg/day in subjects weighing >40 kg. The prednisone dosing was tapered as follows: by the end of wks 1, 2, 4,6,12 and 16, dosages were 0.5, 0.4, 0.3, 0.2, 0.15 and 0.1 mg/kg/day, respectively. The prednisone dose of 0.1 mg/kg was achieved by no later than 6 months post-transplant. |
|
| Tacrolimus | Drug | Taken orally from immediately preoperatively to those>age 5 yrs. (starting dose= 0.1 mg/kg/dose twice daily (BID) for living donor recipients; 0.1 mg/kg/dose daily for deceased donor recipients).Subjects <age 5 yrs. received drug from immediately preoperatively at 0.15 mg/kg/dose BID (two preoperative doses) for living donor recipients and 0.15 mg/kg/dose daily (one preoperative dose) for deceased donor recipients. Postoperatively: 0.07 mg/kg/dose BID w/adjustment to achieve target levels of 12-14 ng/mL (days 0-7), 10-12 ng/mL (wks. 2-8), 7-10 ng/mL (wks. 9-12) &5-7 ng/mL >= 12 wks. Evidence of drug toxicity on any protocol biopsy resulted in a further lowering of the drug target level to 4-6 ng/mL before yr 1 & 3-5 ng/mL after yr 1 post-transplant. This regimen was used in both arms. |
|
|
| Ganciclovir | Drug | Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) Prophylaxis: All participants will receive intravenous ganciclovir 5 mg/kg/day beginning after transplantation until tolerating oral medications, at which time oral valganciclovir will be initiated and continued for a minimum of 100 days. |
|
|
| Valganciclovir | Drug | Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) Prophylaxis: All participants will receive intravenous ganciclovir 5 mg/kg/day beginning after transplantation until tolerating oral medications, at which time oral valganciclovir will be initiated and continued for a minimum of 100 days. |
|
|
| Trimethoprim and sulfamethoxazole | Drug | Pneumocystis pneumonia (PCP)/Urinary Tract Infection (UTI) Prophylaxis: Trimethoprim/sulfamethoxazole (Septra®) 2 mg/kg by mouth will be administered daily at bedtime for a minimum period of the first 6 months post-transplant. If unable to tolerate Septra®, inhaled pentamidine (8 mg/kg to a maximum dose of 300 mg monthly) or Dapsone (2 mg/kg PO to a maximum dose of 100 mg/day) may be substituted for a minimum of the first 6 months post-transplant. For UTI prophylaxis, if Septra® is not tolerated, nitrofurantoin (Macrodantin®), 2.5 mg/kg/day, may be given at bedtime up to a maximum dose of 100 mg/day. |
|
|
| Los Angeles |
| California |
| 90048 |
| United States |
| UCLA - Department of Pediatrics, Division of Nephrology | Los Angeles | California | 90095-1752 | United States |
| Stanford University Medical Center, Lucile Packard Children's Hospital | Palo Alto | California | 94304 | United States |
| UCSF Children's Hospital | San Francisco | California | 94143 | United States |
| University of Florida - Pediatric Nephrology | Gainesville | Florida | 32610-0296 | United States |
| Children's Hospital of New Orleans-Department of Pediatric Nephrology | New Orleans | Louisiana | 70118 | United States |
| Children's Hospital Boston - Division of Nephrology | Boston | Massachusetts | 02115 | United States |
| University of Michigan Medical Center, C.S. Mott Children's Hospital- Division of Nephrology & Transplantation | Ann Arbor | Michigan | 48109 | United States |
| Children's Mercy Hospital - Department of Nephrology | Kansas City | Missouri | 64108 | United States |
| The Children's Hospital of Philadelphia-Department of Nephrology | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital & Regional Medical Center - Division of Nephrology | Seattle | Washington | 98105 | United States |
| Sarwal MM, Vidhun JR, Alexander SR, Satterwhite T, Millan M, Salvatierra O Jr. Continued superior outcomes with modification and lengthened follow-up of a steroid-avoidance pilot with extended daclizumab induction in pediatric renal transplantation. Transplantation. 2003 Nov 15;76(9):1331-9. doi: 10.1097/01.TP.0000092950.54184.67. |
| 15690189 | Background | Vidhun JR, Sarwal MM. Corticosteroid avoidance in pediatric renal transplantation. Pediatr Nephrol. 2005 Mar;20(3):418-26. doi: 10.1007/s00467-004-1786-4. Epub 2005 Feb 3. |
| 15449967 | Background | Vidhun JR, Sarwal MM. Corticosteroid avoidance in pediatric renal transplantation: can it be achieved? Paediatr Drugs. 2004;6(5):273-87. doi: 10.2165/00148581-200406050-00002. |
| 22694755 | Result | Sarwal MM, Ettenger RB, Dharnidharka V, Benfield M, Mathias R, Portale A, McDonald R, Harmon W, Kershaw D, Vehaskari VM, Kamil E, Baluarte HJ, Warady B, Tang L, Liu J, Li L, Naesens M, Sigdel T, Waskerwitz J, Salvatierra O. Complete steroid avoidance is effective and safe in children with renal transplants: a multicenter randomized trial with three-year follow-up. Am J Transplant. 2012 Oct;12(10):2719-29. doi: 10.1111/j.1600-6143.2012.04145.x. Epub 2012 Jun 13. |
| 22694733 | Result | Naesens M, Salvatierra O, Benfield M, Ettenger RB, Dharnidharka V, Harmon W, Mathias R, Sarwal MM; SNS01-NIH-CCTPT Multicenter Trial. Subclinical inflammation and chronic renal allograft injury in a randomized trial on steroid avoidance in pediatric kidney transplantation. Am J Transplant. 2012 Oct;12(10):2730-43. doi: 10.1111/j.1600-6143.2012.04144.x. Epub 2012 Jun 13. |
| 23009139 | Result | Li L, Khatri P, Sigdel TK, Tran T, Ying L, Vitalone MJ, Chen A, Hsieh S, Dai H, Zhang M, Naesens M, Zarkhin V, Sansanwal P, Chen R, Mindrinos M, Xiao W, Benfield M, Ettenger RB, Dharnidharka V, Mathias R, Portale A, McDonald R, Harmon W, Kershaw D, Vehaskari VM, Kamil E, Baluarte HJ, Warady B, Davis R, Butte AJ, Salvatierra O, Sarwal MM. A peripheral blood diagnostic test for acute rejection in renal transplantation. Am J Transplant. 2012 Oct;12(10):2710-8. doi: 10.1111/j.1600-6143.2012.04253.x. |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
ImmPort study identifier is SDY132 |
| SDY132 | Study Protocol | View IPD | ImmPort study identifier is SDY132 |
| SDY132 | Study summary, -design,-demographics, -mechanistic assays, -files et al. | View IPD | ImmPort study identifier is SDY132 |
| FG001 | Steroid-Based Immunosuppression | Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Steroid-Free Immunosuppression | Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details. |
| BG001 | Steroid-Based Immunosuppression | Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details. |
| 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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 | The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation | Standardized Z-scores were computed following a formula using an age- and gender-specific calculation provided by the NHANES III 2000 Growth Data set. The Z-score system expresses anthropometric values of height as several standard deviations (SDs) below (e.g., a negative value) or above (a positive value) the reference mean or median value. In this study the measure was used to test whether there is a difference in the change in height between the treatment groups: Steroid-Based versus Steroid-Free | All Enrolled Subjects | Posted | Mean | Standard Deviation | Standard Deviation Score (SDS) | One year post kidney transplantation procedure |
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| Primary | Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation | Biopsy-proven acute renal (kidney) rejection [1, 2].
| All Enrolled Subjects | Posted | Number | 95% Confidence Interval | Rejection Events | Up to one year post kidney transplantation procedure |
|
Renal (Kidney) transplantation through end of study
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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 | Steroid-Based Immunosuppression | Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details. | 60 | 70 | 64 | 70 | ||
| EG001 | Steroid-Free Immunosuppression | Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details. | 52 | 60 | 56 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Congenital nephrotic syndrome | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastric outlet obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastro-intestinal fistula | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Adverse drug reaction | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Difficulty in walking | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Graft loss | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
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| Kidney transplant rejection | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
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| Transplant rejection | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
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| Abdominal abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Adenovirus infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Application site abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| BK virus infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Central line infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Clostridial infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Clostridium colitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Cytomegalovirus hepatitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Empyema | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Encephalitis viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Collapse of lung | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Graft dysfunction | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Procedural complication | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Treatment noncompliance | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Cytomegalovirus antibody positive | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Cytomegalovirus test positive | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Drug level below therapeutic | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Encephalitis | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Glomerulonephritis focal | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Glomerulonephritis membranoproliferative | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neurogenic bladder | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pelvi-ureteric obstruction | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Urethral obstruction | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vesicoureteric reflux | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Exposure to communicable disease | Social circumstances | MedDRA 11.1 | Systematic Assessment |
| |
| Social problem | Social circumstances | MedDRA 11.1 | Systematic Assessment |
| |
| Stent removal | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
| |
| Air embolism | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arterial thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Incision site complication | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077561 | Daclizumab |
| D009173 | Mycophenolic Acid |
| D011241 | Prednisone |
| D016559 | Tacrolimus |
| D015774 | Ganciclovir |
| D000077562 | Valganciclovir |
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D018942 | Macrolides |
| D007783 | Lactones |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
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