Envarsus XR in African American Renal Transplant Recipients
Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
HaliKuachishwa
Wadhamini
Georgetown University
JARIBIO LA KLINIKI: NCT02956005
BioSeek: nct02956005
Maneno muhimu
Kikemikali
The purpose of this study is to collect data prospectively on African American patients who are taking the immunosuppressant Envarsus post kidney transplant. We are looking to see if African American renal transplant recipients that receive Envarsus will have less tubular injury and calcenurin inhibitor toxicity compared with patients that receive tacrolimus IR.
African americans have the higher rates of CYP3A5 which is associated with the need of higher tacrolimus dose to achieve an adequate level and this many times is associated with signs and symptoms of tacrolimus toxicity such as tremors, headaches and neuropathies.
The retrospective cohort will be African American patients that will be matched by age, gender, type of kidney transplant (living vs deceased) and level of sensitization
Tarehe
| Imethibitishwa Mwisho: | 10/31/2016 |
| Iliyowasilishwa Kwanza: | 11/01/2016 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 11/01/2016 |
| Iliyotumwa Kwanza: | 11/03/2016 |
| Sasisho la Mwisho Liliwasilishwa: | 03/09/2020 |
| Sasisho la Mwisho Lilichapishwa: | 03/23/2020 |
| Tarehe ya matokeo ya kwanza yaliyowasilishwa: | 08/13/2019 |
| Tarehe ya matokeo ya kwanza ya QC yaliyowasilishwa: | 03/09/2020 |
| Tarehe ya matokeo ya kwanza kuchapishwa: | 03/23/2020 |
| Tarehe halisi ya kuanza kwa masomo: | 08/31/2016 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 08/31/2018 |
| Tarehe ya Kukamilisha Utafiti: | 08/31/2018 |
Hali au ugonjwa
Renal Transplant Recipients
Uingiliaji / matibabu
Drug: Envarsus
Awamu
-
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Other: Envarsus Open Label; Envarsus XR started at the time of transplant. Initial dosing of 0.17mg/kg. Target trough level of 8-10 ng/mL | Drug: Envarsus ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: 1. African American race 2. Adult renal transplant recipients (>18 y/o) 3. Previous adverse reaction or contraindication to the use of tacrolimus Exclusion Criteria: 1. Non African American race 2. Less than 18 y/o (pediatric patients) 3. Recipients of liver and small bowel transplants 4. Adverse reaction to tacrolimus |
Matokeo
Hatua za Matokeo ya Msingi
1. Primary Endpoint is to Determine the Rate of Calcineurin Inhibitor Toxicity as Measured by Surveillance Kidney Biopsies. [1 year]
Data not collected - study terminated prematurely when PI left institution.
Hatua za Matokeo ya Sekondari
1. Renal Function After Transplantation [1 year]
Data not collected - study terminated prematurely when PI left institution.
