Early Conversion From Tacrolimus to Efalizumab Maintenance Therapy in Kidney Transplant Recipients

NCT00472082 | Terminated Phase 1 Results DMC

• 2 other identifiers: IRB00003005ACD4056s
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The toxicity of calcineurin inhibitors(CNI)is a major factor limiting the success of renal transplantation. This protocol aims to replace the calcineurin inhibitor, tacrolimus, with efalizumab early after transplantation in patients with mild impairment of renal function in order to minimize the toxicities of CNI.

Conditions

Kidney Transplantation; Chronic Kidney Failure

Keywords

Immunosuppression; Renal Transplantation

Outcome Measures

Primary Outcomes (1)

• Efficacy Will be Determined by Change in Renal Function as Measured by Cold Iothalamate Glomerular Filtration Rate(GFR)3 Months After Enrollment, and Acute Rejection Episodes Within the First 6 Months Post Enrollment.

  6 months from conversion

Secondary Outcomes (1)

• Safety, Including Incidence of Post- Transplant Infections, Malignancies, Morbidities, Hypertension, Glucose Intolerance, Serum Cholesterol and Triglycerides Profile Over Time, Development of New Anti-donor Antibodies.

  1 year

Study Arms (1)

1

EXPERIMENTAL

The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.

Drug: efalizumab

Interventions

efalizumab DRUG

Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study.

Also known as: Raptiva is the brand name FDA approved for the treatment of psoriasis.

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary renal transplant recipients
• recipients of deceased donor or living donor transplant
• Age 18-65 years (inclusive)
• Male or female
• Within 3-9 month window post-transplantation
• No episodes of acute rejection prior to enrollment
• Mild impairment of renal function as defined by a calculated CrCl of 35-50 ml/min/m2

You may not qualify if:

• Subjects with any prior solid organ transplant (including kidney)
• Subjects with a history of panel-reactive antibodies greater than 20% or the development of new anti-HLA antibodies after transplantation and prior to enrollment
• Subjects the Investigator deems to be at a relatively higher risk for acute rejection
• HLA-identical living donor pairs
• Evidence of infection with Hepatitis C (antibody positive or PCR positive), Hepatitis B ( surface antigen positive), HIV
• Subjects with BK or CMV viremia prior to enrollment
• Multiple organ transplant recipients
• Subjects with underlying renal disease of focal segmental glomerulosclerosis, membranoproliferative glomerulonephritis, hemolytic-uremic syndrome/thrombocytopenic purpura syndrome (due to risk of rapid disease recurrence in the allograft
• EBV negative recipients
• Women who are pregnant or nursing
• Women of child bearing age unwilling or unable to use an acceptable method to avoid pregnancy for the duration of the study and up to 8 weeks after last injection
• Patients not able to tolerate a dose of at least 500 mg of mycophenolate mofetil twice daily
• Allergy to Iodine

Sponsors & Collaborators

• Emory University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

efalizumab

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kenneth A. Newell, MD, PhD
• Organization: Emory University

kanewel@emory.edu

404-727-2489

Study Officials

• Kenneth A Newell, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 11, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 27, 2014
• Results First Posted: December 6, 2012

Record last verified: 2013-12

Locations

US (1)