Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation

NCT01046955 | Completed Phase 4

• 1 other identifier: 20010704
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to observe in a randomized prospective study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with the investigators standard treatment protocol of Zenapax® and maintenance immunosuppression.

Conditions

End-Stage Renal Disease; Living Donors

Keywords

ESRD

Outcome Measures

Primary Outcomes (2)

• To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor kidneys.

  3 years

• Patient/graft survival.

  1 and 3 yrs.

Secondary Outcomes (1)

• Incidence of adverse reactions.

  1 & 3 years.

Study Arms (3)

1mg/kg Thymoglobulin

ACTIVE COMPARATOR

LD kidneys receiving 1mg/kg Thymoglobulin for 7 days starting at the day of surgery.

Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab

Campath-1H at 0.3 mg/kg

ACTIVE COMPARATOR

Recipients of LD kidneys receiving Campath-1H at 0.3 mg/kg once on the day of surgery and again 3 days post-operatively.

Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab

Zenapax 1 mg/kg

ACTIVE COMPARATOR

Recipients of LD kidneys receiving Zenapax 1mg/kg on the day of surgery followed by the same dose every 2 weeks for a total of 5 dosages.

Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab

Interventions

Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab DRUG

comparison of induction therapies.

Also known as: Thymoglobulin, Zenapax

1mg/kg Thymoglobulin; Campath-1H at 0.3 mg/kg; Zenapax 1 mg/kg

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>14 years
• Weight \>40 kg
• Primary renal allograft:living related (non HLA identical) and unrelated donor
• Negative standard cross match for T-cells
• Signed and dated consent form

You may not qualify if:

• Patient has previously received or is receiving an organ transplant other than kidney
• Patient has received a kidney transplant from a non-heart beating donor
• Patient has received an ABO incompatible donor kidney
• Recipient or donor is seropositive for human immunodeficiency virus (HIV)
• Patient has a current malignancy or a history of malignancy

Sponsors & Collaborators

• University of Miami: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

University of Miami Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

thymoglobulin; Daclizumab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• George W Burke, M.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 12, 2010
• Study Start: November 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: December 1, 2008
• Last Updated: January 12, 2010

Record last verified: 2008-05

Locations

US (1)