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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506879-98-00 | EU Trial (CTIS) Number |
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The goal of this clinical trial is to compare the degree of HLA sensitization at 2 years in patients with late renal graft failure (> 3 months) when receiving reduced immunosuppressant treatment versus stopping immunosuppression at 6 months.
The main question this study aims to answer is:
Does maintaining long-term immunosuppression in patients with a late renal graft failure (> 3 months) safely reduce the risk of HLA sensitization?
To answer this question, patients will be assigned to a control arm or investigational arm:
Patients recruited in this clinical trial will be followed for up to 2 years. During this time, patients will visit the clinic every 3 months for checkups and tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator |
| |
| Investigational arm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continue low dose calcineurin inhibitor (CNI) | Drug | CNI dose (tacrolimus or cyclosporine) will be adjusted to maintain low tacrolimus or cyclosporine whole blood trough levels from month 3 to month 24 or End of Study |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of HLA sensitization | The difference between the two treatment arms in the degree of HLA sensitization at 2-years measured as cPRA (%). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality for any reason | The difference between the two treatment arms at 2-years on mortality for any reason | 2 years |
| Days of hospitalization for any reason | The difference between the two treatment arms at 2-years on days of hospitalization for any reason |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesc Moreso, MD, PhD | Contact | 93 489 30 00 | francescjosep.moreso@vallhebron.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Vall D'Hebron | Recruiting | Barcelona | 0835 | Spain |
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| Calcineurin inhibitor withdrawal at 6 months | Drug | CNI dose (tacrolimus or cyclosporine) will be reduced to one-half on month 3 visit and completely withdrawn on month 6 visit. |
|
| 2 years |
| Percentage of patients effectively relisted during follow-up | The difference between the two treatment arms at 2-years on percentage of patients effectively relisted during follow-up | 2 years |
| Percentage of patients transplanted | The difference between the two treatment arms at 2-years on percentage of patients transplanted | 2 years |
| Percentage of patients delisted for any reason | The difference between the two treatment arms at 2-years on percentage of patients delisted for any reason | 2 years |
| Incidence of infection | The difference between the two treatment arms at 2-years on incidence of infection | 2 years |
| Incidence of cardiovascular events | The difference between the two treatment arms at 2-years on incidence of cardiovascular events | 2 years |
| Incidence of cancer | The difference between the two treatment arms at 2-years on incidence of cancer | 2 years |
| Incidence of graft-intolerance syndrome requiring graft nephrectomy or percutaneous embolization of the non-functioning graft | The difference between the two treatment arms at 2-years incidence of graft-intolerance syndrome requiring graft nephrectomy or percutaneous embolization of the non-functioning graft | 2 years |
| Erythropoietin resistance index | The difference between the two treatment arms at 2-years on erythropoietin resistance index | 2 years |
| Residual renal function | The difference between the two treatment arms at 2-years on residual renal function | 2 years |
| Number of circulating memory B-cells | The difference between the two treatment arms at 2-years on number of circulating memory B-cells | 2 years |
| Adverse events | The difference in the incidence of adverse events (AE) in the two treatment arms | 2 years |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| 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 |
|---|---|
| D065095 | Calcineurin Inhibitors |
| ID | Term |
|---|---|
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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