Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002378-68 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Carlos III Health Institute | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective is to assess if low pre-transplantation donor specific T-cell reactive patients measured by Enzyme-linked immunosorbent spot (ELISPOT)assay can be safely managed with Calcineurin inhibitor(CNI)-free Sirolimus(SRL)-based immunosuppression.
Non randomized, pilot, prospective, open-label trial.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A- negative pre-transplant ELISPOT | Experimental | Sirolimus: Start at 5 mg/day as soon as treatment allocation arrives to obtain targeting levels to 8 -15 ng/ml (immunoassay) in the first 3 months, followed by trough levels of 5-10 ng/ml. |
|
| B- Positive pre-transplant ELISPOT | Experimental | Tacrolimus 0.1 mg/kg/12h starting as soon as treatment allocation arrives to obtain targeting troughs levels of 8-15 ng/ml the first 3 months, followed by trough levels of 5-10 ng/ml until the end of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRE-TRANSPLANT (PRE=before) | Drug | All patients will start with Thymoglobulin 1 mg/kg before transplant followed by 0,5 mg/kg/d during the next 5 days (total accumulated 3,5 mg/kg). Steroids will be administered at 0,25 mg/kg/d until month 3rd, followed by 0,1 mg/kg/d thereafter. Mycophenolate Mofetil: Pre-transplant 2 grams iv. After transplantation 1g/12 hours, starting iv and changing to oral formulation as soon as patient starts with oral intake (targeting mycophenolic acid (MPA) C0h levels 2-5 µg/mL). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of biopsy-confirmed acute rejection episodes | To describe cumulative biopsy-confirmed acute rejection in both groups by intention to treat analysis. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of steroid-sensitive acute rejection episodes | To describe the percentage of steroid-sensitive acute rejections rejection in both groups by intention to treat analysis. | 6 months |
| Percentage of acute rejection episodes requiring treatment with antilymphocyte antibodies. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Josep M Grinyó, PhD MD | Nephrology Department. Hospital de Bellvitge. Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrology Department. Hospital Vall d'Hebró | Barcelona | Barcelona | 08035 | Spain | ||
| Nephrology Department. Hospital de Bellvitge |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17878390 | Background | Bestard O, Cruzado JM, Mestre M, Caldes A, Bas J, Carrera M, Torras J, Rama I, Moreso F, Seron D, Grinyo JM. Achieving donor-specific hyporesponsiveness is associated with FOXP3+ regulatory T cell recruitment in human renal allograft infiltrates. J Immunol. 2007 Oct 1;179(7):4901-9. doi: 10.4049/jimmunol.179.7.4901. | |
| 23763435 |
| Label | URL |
|---|---|
| This is the center in Spain for the central contact and the main location including patients. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
To describe the need for antibody treatment in acute rejection episodes in both groups by intention to treat analysis. |
| 6 months |
| Renal function estimated by Modification of Diet in Renal Disease (MDRD) formula. | To describe renal function measured by MDRD in both groups by intention to treat and "on therapy" analysis. | 12 months |
| Proteinuria measured in g/day | To describe proteinuria in g/day in both groups by intention to treat analysis. | 6 months |
| Histology at month 6 protocol kidney allograft biopsy | To describe histology at month 6 in both groups by intention to treat and "on therapy" analysis. | 6 months |
| Percentage of patients with negative ELISPOT | To describe percentage of patients with negative ELISPOT in both groups by intention to treat and "on therapy" analysis. | 6 months |
| Percentage of patients in group A requiring CNI introduction. | To describe the percentage of patients in group A requiring CNI introduction. | 24 months |
| Percentage of patients presenting adverse events requiring study withdrawal | To describe adverse events in the whole group ("screening failure" plus "intention to treat") in both treatments groups. | 24 months |
| Percentage of biopsy-confirmed acute rejection episodes | To describe cumulative biopsy-confirmed acute rejection in both groups by intention to treat analysis. | 12 months |
| Percentage of steroid-sensitive acute rejections rejection episodes | To describe the percentage of steroid-sensitive acute rejections rejection in both groups by intention to treat analysis. | 12 months |
| Percentage of acute rejection episodes requiring treatment with antilymphocyte antibodies | To describe the need for antibody treatment in acute rejection episodes in both groups by intention to treat analysis. | 12 months |
| Proteinuria measured in g/day | To describe proteinuria in g/day in both groups by intention to treat analysis. | 12 months |
| Percentage of patients with negative ELISPOT | To describe percentage of patients with negative ELISPOT in both groups by intention to treat and "on therapy" analysis. | 12 months |
| L'Hospitalet de Llobregat |
| Barcelone |
| 08907 |
| Spain |
| Bestard O, Crespo E, Stein M, Lucia M, Roelen DL, de Vaal YJ, Hernandez-Fuentes MP, Chatenoud L, Wood KJ, Claas FH, Cruzado JM, Grinyo JM, Volk HD, Reinke P. Cross-validation of IFN-gamma Elispot assay for measuring alloreactive memory/effector T cell responses in renal transplant recipients. Am J Transplant. 2013 Jul;13(7):1880-90. doi: 10.1111/ajt.12285. Epub 2013 Jun 13. |
| 23783240 | Result | Bestard O, Cruzado JM, Lucia M, Crespo E, Casis L, Sawitzki B, Vogt K, Cantarell C, Torras J, Melilli E, Mast R, Martinez-Castelao A, Goma M, Reinke P, Volk HD, Grinyo JM. Prospective assessment of antidonor cellular alloreactivity is a tool for guidance of immunosuppression in kidney transplantation. Kidney Int. 2013 Dec;84(6):1226-36. doi: 10.1038/ki.2013.236. Epub 2013 Jun 19. |