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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| University of Arizona | OTHER |
| Wake Forest University | OTHER |
| University of Nebraska |
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In a non-blinded pilot study conducted at the University of Nebraska Medical Center, evidence was found that a single large dose of Thymoglobulin on the day of kidney transplantation produced better kidney function than the standard dosing plan, when the same amount is divided into smaller doses on 4 days. This new study repeats that dose comparison, but with double-blinding and at multiple transplantation centers.
This study is designed to confirm the one-year safety of single-dose rabbit anti-thymocyte globulin induction at kidney transplantation, compared to the conventional administration of the same overall dose divided into four smaller doses across four days. Two randomized groups of kidney transplant recipients will be each administered the drug Thymoglobulin according to a different dosing regimen. The control group will receive the usual and traditional regimen of a total of 6 mg/Kg divided into 4 doses, 1 on the day of transplantation and 1 each day on the next 3 days. The experimental group will receive the same total Thymoglobulin dose, 6 mg/Kg, but entirely on the day of transplantation.
The study will be double-blinded, with placebo doses of Thymoglobulin administered as needed to enrollees in the experimental group. Enrollment is targeted at 165, with 150 subjects needed to complete the study for adequate evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-dose Thymoglobulin | Experimental | Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion |
|
| Divided-dose Thymoglobulin | Active Comparator | Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-dose rabbit Anti-thymocyte Globulin induction | Biological | 6 mg of rATG administered in a single dose on the day of kidney transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function | The composite endpoint components and definitions are:
| During first 7 days after kidney transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival | Kaplan-Meier estimate of the number of patients who survived for the 12 months after kidney transplantation. | 12 months post-transplantation |
| Graft Survival | Kaplan-Meier estimates of graft survival probability for 12 months after transplantation |
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Inclusion Criteria:
Exclusion Criteria:
Relative Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R.Brian Stevens, MD, PhD | Wright State University, Dayton, Ohio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | United States | ||
| University of Nebraska Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18497677 | Background | Stevens RB, Mercer DF, Grant WJ, Freifeld AG, Lane JT, Groggel GC, Rigley TH, Nielsen KJ, Henning ME, Skorupa JY, Skorupa AJ, Christensen KA, Sandoz JP, Kellogg AM, Langnas AN, Wrenshall LE. Randomized trial of single-dose versus divided-dose rabbit anti-thymocyte globulin induction in renal transplantation: an interim report. Transplantation. 2008 May 27;85(10):1391-9. doi: 10.1097/TP.0b013e3181722fad. | |
| 25083614 |
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Occasionally patients were evaluated and thought to be suitable trial candidates until transplantation was imminent, when they were ruled out by last-minute observation of medical problems or donor shortcomings.
Trial enrollment occurred between 3/30/2010 and 3/25/2014. Patients scheduled to undergo kidney transplantation were evaluated for trial suitability/enrollment in the transplant hospital or clinic just before transplantation, typically from a few hours to ~24 hours before transplantation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-dose Thymoglobulin | Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation |
| FG001 | Divided-dose Thymoglobulin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Primary Endpoint (Early Safety) |
|
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| OTHER |
| The Methodist Hospital Research Institute | OTHER |
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|
| Divided-dose rabbit Anti-thymocyte Globulin induction | Biological | 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation. |
|
|
| 12 months post-transplantation |
| Acute Kidney Rejection | Kaplan-Meier probability estimates of rejection rates | 12 months post-transplantation |
| Incomplete Thymoglobulin Infusion | First 7 days post-transplantation |
| Kidney Function | Estimated Glomerular Filtration Rate using the abbreviated MDRD formula (Modification of Diet in Renal Disease study) | 12 months post-transplantation |
| Omaha |
| Nebraska |
| 68198 |
| United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | United States |
| Background |
| Stevens RB, Foster KW, Miles CD, Lane JT, Kalil AC, Florescu DF, Sandoz JP, Rigley TH, Nielsen KJ, Skorupa JY, Kellogg AM, Malik T, Wrenshall LE. A randomized 2x2 factorial trial, part 1: single-dose rabbit antithymocyte globulin induction may improve renal transplantation outcomes. Transplantation. 2015 Jan;99(1):197-209. doi: 10.1097/TP.0000000000000250. |
| 26696251 | Derived | Stevens RB, Wrenshall LE, Miles CD, Farney AC, Jie T, Sandoz JP, Rigley TH, Osama Gaber A. A Double-Blind, Double-Dummy, Flexible-Design Randomized Multicenter Trial: Early Safety of Single- Versus Divided-Dose Rabbit Anti-Thymocyte Globulin Induction in Renal Transplantation. Am J Transplant. 2016 Jun;16(6):1858-67. doi: 10.1111/ajt.13659. Epub 2016 Mar 7. |
Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation. |
| COMPLETED |
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| NOT COMPLETED |
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| Secondary Endpoints (Long-term Safety) |
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Patients who received a kidney transplant along with the study intervention, either single-dose or divided-dose rabbit anti-thymocyte globulin.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-dose Thymoglobulin | Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation |
| BG001 | Divided-dose Thymoglobulin | Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation. |
| 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 |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Type of kidney donor | Number | participants |
|
| 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 | Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function | The composite endpoint components and definitions are:
| Posted | Number | participants | During first 7 days after kidney transplantation |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Survival | Kaplan-Meier estimate of the number of patients who survived for the 12 months after kidney transplantation. | Posted | Number | participants | 12 months post-transplantation |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Graft Survival | Kaplan-Meier estimates of graft survival probability for 12 months after transplantation | Posted | Number | participants | 12 months post-transplantation |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Acute Kidney Rejection | Kaplan-Meier probability estimates of rejection rates | Posted | Number | participants | 12 months post-transplantation |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incomplete Thymoglobulin Infusion | Posted | Number | participants | First 7 days post-transplantation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kidney Function | Estimated Glomerular Filtration Rate using the abbreviated MDRD formula (Modification of Diet in Renal Disease study) | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | 12 months post-transplantation |
|
|
One year.
Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
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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 | Single-dose Thymoglobulin | Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation | 23 | 44 | 44 | 44 | ||
| EG001 | Divided-dose Thymoglobulin | Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation. | 21 | 51 | 49 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| serum sickness | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Congestive heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Atypical chest pain | Cardiac disorders | Systematic Assessment |
| ||
| hyperkalemia | Endocrine disorders | Systematic Assessment |
| ||
| abdominal fullness | Gastrointestinal disorders | Systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| nausea | Gastrointestinal disorders | Systematic Assessment |
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| death | General disorders | Systematic Assessment |
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| orthostatic hypotension | General disorders | Systematic Assessment |
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| cholangitis | Hepatobiliary disorders | Systematic Assessment |
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| hepatitis C exposure | Hepatobiliary disorders | Systematic Assessment |
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| Leukopenia | Immune system disorders | Systematic Assessment |
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| BK virus | Infections and infestations | Systematic Assessment |
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| C. difficile | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Histoplasmosis | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
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| Viral Gasteroenteritis | Infections and infestations | Systematic Assessment |
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| rATG reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Chronic lymphoid leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Seizures | Nervous system disorders | Systematic Assessment |
| ||
| Acute tubular necrosis | Renal and urinary disorders | Systematic Assessment | After post-transplantation day 7 |
| |
| Delayed graft function | Renal and urinary disorders | Systematic Assessment |
| ||
| Interstitial nephritis | Renal and urinary disorders | Systematic Assessment |
| ||
| Native nephrectomy | Renal and urinary disorders | Systematic Assessment |
| ||
| Nephrostomy tube placement | Renal and urinary disorders | Systematic Assessment |
| ||
| Perinephric hematoma | Renal and urinary disorders | Systematic Assessment |
| ||
| Rejection | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal vein thrombosis | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wound hernia repair | Surgical and medical procedures | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hemorrhage | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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| Hypotension | Cardiac disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Hyperglycemia | Endocrine disorders | Systematic Assessment |
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| Hyperkalemia | Endocrine disorders | Systematic Assessment |
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| Hyperparathyroidism | Endocrine disorders | Systematic Assessment |
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| Hyperphosphatemia | Endocrine disorders | Systematic Assessment |
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| Hypokalemia | Endocrine disorders | Systematic Assessment |
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| Hypomagnesemia | Endocrine disorders | Systematic Assessment |
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| Hypophosphatemia | Endocrine disorders | Systematic Assessment |
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| Osteopenia | Endocrine disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Gastric reflux | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Edema | General disorders | Systematic Assessment |
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| Orthostatic hypotension | General disorders | Systematic Assessment |
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| Tacrolimus elevation/toxicity | General disorders | Systematic Assessment |
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| Elevated liver enzymes | Hepatobiliary disorders | Systematic Assessment |
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| Leukocytosis | Immune system disorders | Systematic Assessment |
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| Leukopenia | Immune system disorders | Systematic Assessment |
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| Neutropenia | Immune system disorders | Systematic Assessment |
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| BK virus | Infections and infestations | Systematic Assessment |
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| Pancytopenia | Immune system disorders | Systematic Assessment |
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| C. difficile | Infections and infestations | Systematic Assessment |
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| Respiratory infection | Infections and infestations | Systematic Assessment | Includes colds, sinusitis, bronchitis |
| |
| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Possible rATG reaction | Injury, poisoning and procedural complications | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperlipidemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | Systematic Assessment |
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| Elevated serum creatinine | Renal and urinary disorders | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | Systematic Assessment |
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| Rejection | Renal and urinary disorders | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hernia | Surgical and medical procedures | Systematic Assessment |
| ||
| Wound complication | Surgical and medical procedures | Systematic Assessment | Includes wound hematoma, seroma, drainage, slow healing |
|
After an interim analysis at the trial mid-point, the trial was terminated because a futility trend analysis showed a >1.72% chance of the primary endpoint rates between the two groups achieving a significant difference with further enrollment.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. R. Brian Stevens, MD, PhD, FACS | Wright State University Boonshoft School of Medicine, Dayton, Ohio, USA | 937-545-4817 | rbstevens1@icloud.com |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C512542 | thymoglobulin |
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| >=65 years |
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| Male |
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| Deceased donor |
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