- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01433770
Alefacept in Kidney Transplant Recipients
Effects of Alefacept on Donor-Specific Memory in Kidney Transplant Recipients
Alefacept, also known as Amevive®, is a medication approved by the Food and Drug Administration (FDA) in the United States and other countries for the treatment of psoriasis, which is a chronic inflammatory immunological skin condition that can result in chronic dry, red patches that are covered in scales. Alefacept is approved by the FDA for the treatment of psoriasis but not as an anti-rejection medication in transplant patients. It is now being tested in new kidney transplant patients as a supplement to other approved anti-rejection drugs. Alefacept will be used as an investigational drug in this study.
The reason for this study is to test whether using Alefacept will inhibit T cells, known as memory cells, using a test named ELISPOT-IFN. In patients with psoriasis, Alefacept inhibits these memory cells. If memory cells specific to your donor can be inhibited by this drug, it might prevent rejection and promote acceptance of the transplanted kidney in a unique manner.
Panoramica dello studio
Tipo di studio
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Ohio
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Cleveland, Ohio, Stati Uniti, 44106
- University Hospitals Case Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Able and willing to sign informed consent
- Adult (>18years) kidney-alone transplant recipient
- 6 months post-transplant
- Persistently positive donor-stimulated ELISPOT-IFN (≥30 spots/300K cells)-2 positive assays separated by at least one week
- Female subjects of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment and must agree to maintain effective birth control during the study
Exclusion Criteria:
- Baseline CD4 count <250 cells/uL
- Acute rejection episode within the 3 months prior to enrollment
- Clinically overt infection within the 3 months prior to enrollment
- History of BK polyoma viremia
- Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
- Subject has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
- Any major illnesses/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study, or could preclude the evaluation of the subject's response
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Alefacept action on memory T cells
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Alefacept 15mg subcutaneous; once a week for 12 weeks
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Absolute changes in ELISPOTS, PRT (Panel Reactive T Cells), and lymphocyte subsets will be analyzed using paired t-tests to compare baseline vs 4, 8, 12, 16, and 24 weeks of follow-up
Lasso di tempo: 12, 24, and 36 months
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12, 24, and 36 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
The incidence of clinically overt infections will be descriptive or calculated as a simple percentage.
Lasso di tempo: 12, 24, and 36 months
|
12, 24, and 36 months
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Donald E Hricik, MD, University Hospitals Cleveland Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 02-11-06
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .