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The purpose of this study is to assess the clinical efficacy of the LCPT En-varsus [Life-Cycle Pharma Tacrolimus] initiated in de novo (Day 0 of transplantation) using the Biopsy Proven Acute Re-jection and iBox (full and abbreviated algo-rithms).
NovoStart is a descriptive study, prospective, multicenter, real-world evidence de-signed to evaluate the clinical efficacy and safety of Once-Daily Extended-Release Tacroli-mus in kidney transplantation using the iBox prognostic system.
The NovoStart study will be conducted at 13 academic hospitals in France performing kidney transplants.
The study population will comprise three cohorts of patients:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort of patients treated | Cohort of patients treated with Life-Cycle Pharma Tacrolimus-based immunosuppression: Our single-arm study addresses the primary objective. |
| |
| Reference cohort for transplants | Cohorts Transplant reference: two control groups (Tacrolimus twice daily (IR-Tac) and Tacrolimus once daily (ER-Tac)) to determine the main secondary objective. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Life-Cycle Pharma Tacrolimus | Drug | Patients receiving LCPT Envarsus® [Life-Cycle Pharma Tacrolimus] within 24 hours of kidney transplantation in a once-daily formulation at the discretion of the investiga-tor and in compliance with the summary of product characteristics (SmPC). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Biopsy Proven Acute Rejection | The primary endpoint is the incidence of Biopsy Proven Acute Rejection between the Life-Cycle Pharma Tacrolimus cohort and the control groups of the transplant reference cohort. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe GATAULT, MD | Contact | 247366392 | +33 | philippe.gatault@univ-tours.fr |
| Yoni ATHEA, Dr. | Contact | 147684930 | +33 | y.athea@chiesi.com |
| Name | Affiliation | Role |
|---|---|---|
| Philippe GATAULT, MD | CHRU TOURS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chru Tours | Tours | 37044 | France |
|
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D016030 | Kidney Transplantation |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
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|
| Kidney transplantation | Procedure | Kidney transplant patients using the iBox prognostic system (risk prediction system for kidney transplants) |
|
| 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 |
| D013514 |
| Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |