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.
Studieoversikt
Studietype
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- University Hospitals Case Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Alefacept action on memory T cells
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Alefacept 15mg subcutaneous; once a week for 12 weeks
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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
Tidsramme: 12, 24, and 36 months
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12, 24, and 36 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The incidence of clinically overt infections will be descriptive or calculated as a simple percentage.
Tidsramme: 12, 24, and 36 months
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12, 24, and 36 months
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Donald E Hricik, MD, University Hospitals Cleveland Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 02-11-06
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