A Trial of Two Daclizumab Dosing Strategies vs. No Induct... | NCT00363116

Studies
A Trial of Two Daclizumab Dosing Strategies vs. No Induction Treatment With Tacrolimus, Mycophenolate Mofetil , & Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients

NCT00363116

Sponsor

University of Cincinnati

Status

Completed

Last Update Posted

Oct 25, 2013Estimated

Enrollment

298Actual

Phase

Phase 4

Conditions

Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients

Interventions

Daclizumab

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1999

Primary Completion Date

Dec 2004Actual

Completion Date

Dec 2004Actual

First Submitted Date

Aug 10, 2006

First Submission Date that Met QC Criteria

Aug 10, 2006

First Posted Date

Aug 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2013

Last Update Posted Date

Oct 25, 2013Estimated

Name	Class
Roche Pharma AG	INDUSTRY
University of Tennessee	OTHER

Description Module

Brief Summary

The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients.

Detailed Description

The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab as an adjunctive immunosuppressive agent in simultaneous kidney/pancreas transplant recipients receiving tacrolimus, mycophenolate mofetil, and steroids as primary maintenance immunosuppression.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

298Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
5 Dose Daclizbumab	Active Comparator	daclizumab 1 mg/kg/dose every 14 days for 5 doses	Drug: Daclizumab
2 Dose Daclizaumab	Active Comparator	daclizumab 2 mg/kg/dose every 14 days for 2 doses	Drug: Daclizumab
Control	Active Comparator	no antibody induction	Drug: Daclizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Daclizumab	Drug	daclizumab 1 mg/kg/dose every 14 days for 5 doses	2 Dose Daclizaumab 5 Dose Daclizbumab Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the incidence of presumed acute kidney or pancreas rejection, death, and kidney or pancreas graft loss in the first 6 months post transplant.

Secondary Outcomes

Measure	Description	Time Frame
Incidence, timing and severity of fungal infections.
Incidence, timing and severity of malignancies.
Hospitalizations.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Simultaneous kidney/pancreas transplant recipients
Insulin dependent Type 1 or 2 diabetes pretransplant
Recipient age 18-65 years
Donor age 5-65 years
Women must have negative serum pregnancy test and practice birth control for study duration
Negative T-cell crossmatch
Parent (or guardian) is able to understand the consent form and give written informed consent

Exclusion Criteria:

Prior treatment with daclizumab
Known sensitivity or contraindication to tacrolimus, MMF, or steroids
Patient with significant or active infection
Patients with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum
Patients whose life expectancy is severely limited by diseases other than renal disease
Ongoing substance abuse, drug or alcohol
Major ongoing psychiatric illness or recent history of noncompliance
Insufficient cardiovascular reserve
Malignancy within last 5 years, excluding nonmelanoma skin cancers
Serologic evidence of infection with HIV or Hepatitis B surface antigen positive
Investigational drug within 30 days prior to transplant surgery
Anti-T cell therapy within 30 days prior to transplant surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert J Stratta, MD	University of Tennessee	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California - Davis		Davis	California	95616	United States
University of California - Los Angeles

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins