Effect of Rapid Steroid Withdrawal on Subclinical Markers... | NCT00133172

Studies
Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection

NCT00133172

Sponsor

Astellas Pharma Inc

Status

Terminated

Last Update Posted

Sep 8, 2014Estimated

Enrollment

85Actual

Phase

Phase 4

Conditions

Kidney Transplantation

Interventions

Tacrolimus
mycophenolate mofetil
Prednisone

Countries

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Varience of supply chain from that required by protocol

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Aug 22, 2005

First Submission Date that Met QC Criteria

Aug 22, 2005

First Posted Date

Aug 23, 2005Estimated

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

Sep 5, 2014

Last Update Posted Date

Sep 8, 2014Estimated

Name	Class
Astellas Pharma Canada, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

85Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Steroid rapid 5-day withdrawal	Drug: Tacrolimus Drug: mycophenolate mofetil Drug: Prednisone
2	Active Comparator	Standard steroid maintenance	Drug: Tacrolimus Drug: mycophenolate mofetil Drug: Prednisone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tacrolimus	Drug	IV	1 2	Prograf FK506

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR)		3 months post transplant

Secondary Outcomes

Measure	Description	Time Frame
Biopsy proven chronic allograft nephropathy(CAN)		2 years post transplant
Patient and graft survival rates		End of study (5 years)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures.
Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant.
Subject is 18 years of age or over at the time of transplant.
If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods

Exclusion Criteria:

Recipients of a kidney from a donor 60 years of age or older
Recipients of donation after cardiac death (DCD) donors
Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart)
Subjects with a second renal allograft who had their original graft for < 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure
Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) >20
Subjects with hepatitis B & C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma)
Subjects receiving an allograft with cold ischemia time 24 hours or greater
Subjects who have received an investigational drug within three months prior to randomization
Subjects who are breastfeeding
Subjects with known hypersensitivity to tacrolimus, mycophenolate mofetil, methylprednisolone, basiliximab, prednisone, or any related drugs or their excipients
Subjects with significant disease (e.g. uncontrolled infection) or disability (e.g. cognitive deficit) that prevents understanding of or adherence to the protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Calgary	Alberta	T2N 2T9	Canada

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D002208	Caproates
D000144

ID	Term
D016559	Tacrolimus
D009173	Mycophenolic Acid
D011241	Prednisone