Trials / Unknown
UnknownNCT03828682
Veloxis de Novo Kidney Transplant ECSWD
A 12-Month, Open Label Study of Extended Release Tacrolimus (Envarsus XR®, LCPT) With Mycophenolate, Rabbit Antithymocyte Globulin (rATG) and Early Steroid Withdrawal in de Novo Kidney Transplant Recipients
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Simon Tremblay, PharmD, PhD · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to evaluate the safety and efficacy of LCPT in combination with rATG, mycophenolate and early corticosteroid withdrawal (CSWD) in de novo kidney transplant recipients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tacrolimus Extended Release Oral Tablet [Envarsus] | Tacrolimus Extended Release Oral Tablet \[Envarsus\] |
| DRUG | Mycophenolate Mofetil | Mycophenolate mofetil capsules or tablets |
| DRUG | Mycophenolic Acid Oral Product | mycophenolic acid tablets |
| DRUG | Tacrolimus | Twice daily tacrolimus |
| DRUG | Methylprednisolone | Methylprednisolone taper |
| DRUG | Prednisone | Prednisone taper |
| DRUG | Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin] | Rabbit Anti-Human T-Lymphocyte Globulin |
Timeline
- Start date
- 2019-06-21
- Primary completion
- 2021-07-31
- Completion
- 2022-06-30
- First posted
- 2019-02-04
- Last updated
- 2020-05-13
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03828682. Inclusion in this directory is not an endorsement.