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| Name | Class |
|---|---|
| Clinical Trials in Organ Transplantation | NETWORK |
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This study is a multicenter, non-randomized, retrospective study to collect long term (5 years post-transplant) clinical outcome data to test whether the results of the noninvasive immune monitoring test strategy performed in the parent study (CTOT-01, NCT00308802) in first six-month post-transplant is predictive of 5-year outcomes. Each center will complete a retrospective chart review for the data on patient survival, graft survival and renal function.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in estimated glomerular filtration Rate (eGFR) from 6 months to 5 years post-transplantation | Modification of Diet in Renal Disease (MDRD) in the adult cohort and Schwartz method in the pediatric cohort | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient survival as assessed by the incidence of death reported in the first 5 years post- transplant | Day 1 | |
| Graft survival as assessed by the incidence of graft loss reported in the first 5 years post- transplant | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population was selected based on their previous participation in the parent study (CTOT-01). A total of 280 subjects were enrolled and transplanted in the Clinical Trials in Organ Transplantation
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| Name | Affiliation | Role |
|---|---|---|
| Peter S Heeger, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Donald E Hricik, MD | University Hospitals Cleveland Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29189482 | Result | Faddoul G, Nadkarni GN, Bridges ND, Goebel J, Hricik DE, Formica R, Menon MC, Morrison Y, Murphy B, Newell K, Nickerson P, Poggio ED, Rush D, Heeger PS; CTOT-17 consortium. Analysis of Biomarkers Within the Initial 2 Years Posttransplant and 5-Year Kidney Transplant Outcomes: Results From Clinical Trials in Organ Transplantation-17. Transplantation. 2018 Apr;102(4):673-680. doi: 10.1097/TP.0000000000002026. |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| SDY1094 | Individual Participant Data Set | View IPD |
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| Renal function as assessed by the absolute glomerular filtration Rate (GFR) at 5 years post-transplant | Day 1 |
| Change in Chronic Kidney Disease stages between transplant and 5 years post- transplant | Day 1 |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation, Glickman Urological Institute | Cleveland | Ohio | 44195 | United States |
| University of Manitoba Health Sciences Centre | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Children's Hospital of Winnipeg | Winnipeg | Manitoba | Canada |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
| Clinical Trials in Organ Transplantation (CTOT) | View source |
Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts. Data analysis tools are also available to researchers. |
| SDY1094 | Study Protocol | View IPD | ImmPort study identifier is SDY1094. |
| SDY1094 | Study summary, -design, -summary of participant assessments, -interventions, -medications, -demographics, -lab tests, -study files et al. | View IPD | ImmPort study identifier is SDY1094. |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012919 | Social Behavior |
| D001519 | Behavior |
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