Panel Reactive Antibody (PRA) Reduction in Sensitized Patients Awaiting Renal Transplantation

NCT00784979 | Completed Phase 4 Results

• 1 other identifier: IIS_100109
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to offer Panel Reactive Antibodies \[PRA\] reduction treatment to high responder renal transplant patients who otherwise may never be compatible with a potential organ donor. PRA reduction is offered in the following phases:

1. 1.Immunological Testing
2. 2.Transplant Nephrectomy
3. 3.Pharmacologic Therapy
4. 4.Plasmapheresis
5. 5.Transplant

Conditions

End Stage Renal Disease

Keywords

Renal; Transplant; PRA

Outcome Measures

Primary Outcomes (1)

• The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor

  The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation.

  four weeks

Secondary Outcomes (2)

• Monitor Graft Survival

  5 years

• Monitor Patient Survival

  5 years

Study Arms (1)

CMVIG followed by PP

NO INTERVENTION

MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis

Drug: CMVIG

Interventions

CMVIG DRUG

400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks

Also known as: Cytomegalovirus Immune Globulin - Intravenous, Cytogam

CMVIG followed by PP

Eligibility Criteria

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

You may qualify if:

• Renal transplant recipients with a potential living donor who is incompatible (T-\&/or B-cell locus) due to recipient high PRA or MHC antibodies
• PRA greater than or equal to 20% within last twelve months
• Recipient and donor accepted as potential candidates by the LifeLink Healthcare Renal Transplant Committee

You may not qualify if:

• Patients with known allergy to CytoGam(R), Cellcept, Rapamycin
• Patients who will receive IVIG or CytoGam(R) for any cause prior to protocol process
• ABO incompatibility
• Patients not capable of following through the treatment for various reasons as determined by treating physicians
• Any potential recipient who is pregnant or becomes pregnant

Sponsors & Collaborators

• Tampa General Hospital: lead
• CSL Behring: collaborator

Study Sites (1)

LifeLink HealthCare Institute

Tampa, Florida, 33606, United States

Location

Related Links

• Tampa General Medical Group

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

cytomegalovirus-specific hyperimmune globulin

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: Dr. John Leone
• Organization: Tampa General Hospital

jpleone@tgh.org

813-844-5666

Study Officials

• John Leone, MD, PhD

  Lifelink Healthcare Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: January 1, 2002
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2012
• Last Updated: June 29, 2015
• Results First Posted: June 29, 2015

Record last verified: 2015-06

Locations

US (1)