Clinical trial NCT00365846: "A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation"
Official title: "A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Transplant
Keywords: prevent kidney rejection
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2006-08-18
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to see if campath-1H can be used in first time renal transplant subjects to prevent rejection and reduce the overall amount of anti-rejection medications that patients take on a daily basis.

Detailed description: Twenty nine primary recipients of either a live donor or deceased donor renal transplant were enrolled in this study. Subjects were administered two 20mg doses of Campath-1H antibody therapy (Day 0 and Day 1) in combination with a short course of corticosteroids, and maintenance sirolimus.

Subjects were followed for 3 years to compare the incidence and severity of rejection episodes, complications related to the immunosuppression, including infections, malignancies and adverse events. All subjects underwent protocol renal transplant biopsies at 6 and 12 months (unless medically contraindicated).

Eligibility criteria: Inclusion Criteria:

* primary renal transplant (not HLA identical)
* ages 18-60 years

Exclusion Criteria:

* recipient panel reactive antibody level \>10%
* recipient of a DCD kidney
* no prior organ transplant
* no multi-organ transplant recipient
* no subject who is currently receiving systemic corticosteroids
* no pregnant or lactating subjects
* no history of Hepatitis B, C or HIV positivity
* no recipient of a kidney with cold ischemia time \>36 hours

Primary outcomes:
measure: Incidence of Allograft Rejection
timeFrame: 3 years
Secondary outcomes:
measure: Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment)
timeFrame: 3 years
measure: Patient Survival
timeFrame: 3 years
measure: Incidence of Post-transplant Infection
timeFrame: 3 years
measure: Incidence of Malignancies
timeFrame: 3 years
measure: Kidney Allograft Survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Stuart J Knechtle
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barth RN, Janus CA, Lillesand CA, Radke NA, Pirsch JD, Becker BN, Fernandez LA, Thomas Chin L, Becker YT, Odorico JS, D'Alessandro AM, Sollinger HW, Knechtle SJ. Outcomes at 3 years of a prospective pilot study of Campath-1H and sirolimus immunosuppression for renal transplantation. Transpl Int. 2006 Nov;19(11):885-92. doi: 10.1111/j.1432-2277.2006.00388.x.
citation: Fehr T, Hubel K, de Rougemont O, Abela I, Gaspert A, Gungor T, Hauri M, Helmchen B, Linsenmeier C, Muller T, Nilsson J, Riesterer O, Scandling JD, Schanz U, Cippa PE. Successful Induction of Specific Immunological Tolerance by Combined Kidney and Hematopoietic Stem Cell Transplantation in HLA-Identical Siblings. Front Immunol. 2022 Jan 31;13:796456. doi: 10.3389/fimmu.2022.796456. eCollection 2022.