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Phase IV, randomized, open-label study comparing the use of Grafalon® versus Thymoglobulin® in non-sensitized patients who have received a kidney transplant at high risk of delayed graft function

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526938-23-00
Enrollment
104
Registered
2026-10-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Kidney transplantation

Brief summary

Lymphocyte values throughout follow-up.

Detailed description

Hemoglobin, leukocyte, neutrophil, and platelet values throughout follow-up., Number of patients requiring the use of granulopoietic colony-stimulating factors throughout follow-up., Number of patients who develop infections throughout follow-up., Number of viral, bacterial, or fungal infections in the study populations, Number of patients with repeated or recurrent infections, Number of patients requiring hospital admission for infections, Number of patients with a satisfactory or unsatisfactory course due to infectious complications., Number of patients requiring discontinuation of any of the drugs due to serious adverse effects., Number of patients in whom the remaining treatment must be modified due to adverse events associated with the use of the study drugs., Number of patients in whom maintenance immunosuppression is discontinued., Number of patients in whom prophylactic treatment is discontinued., Number of patients who develop AR in the first 3 months after transplantation, Number of patients who develop AR in the first year after transplantation, Number of cellular mediated rejection episodes, Number of episodes of antibody mediated rejection, Number of patients presenting with functioning kidney graft, Mean renal function measured by serum Cr (mg/dl), Proteinuria in 24-h urine or protein/creatinine ratio (mg/g), Number of patients who develop DGF in the immediate post-transplant period, Number of patients presenting with PGD., levels of the maintenance immunosuppressive treatment used in each case., Number of cancers during follow-up.

Interventions

DRUGGrafalon 20 mg/ml concentrado para solución para perfusión

Sponsors

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Lymphocyte values throughout follow-up.—

Secondary

MeasureTime frame
Hemoglobin, leukocyte, neutrophil, and platelet values throughout follow-up., Number of patients requiring the use of granulopoietic colony-stimulating factors throughout follow-up., Number of patients who develop infections throughout follow-up., Number of viral, bacterial, or fungal infections in the study populations, Number of patients with repeated or recurrent infections, Number of patients requiring hospital admission for infections, Number of patients with a satisfactory or unsatisfactory course due to infectious complications., Number of patients requiring discontinuation of any of the drugs due to serious adverse effects., Number of patients in whom the remaining treatment must be modified due to adverse events associated with the use of the study drugs., Number of patients in whom maintenance immunosuppression is discontinued., Number of patients in whom prophylactic treatment is discontinued., Number of patients who develop AR in the first 3 months after transplantation, Nu—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 20, 2026