Minimizing Immunosuppression in Old for Old Kidney Transp... | NCT00912678

Studies
Minimizing Immunosuppression in Old for Old Kidney Transplantation

NCT00912678

Sponsor

University of Luebeck

Status

Completed

Last Update Posted

Jun 3, 2009Estimated

Enrollment

90Actual

Phase

Phase 4

Conditions

Kidney Transplantation

Interventions

MMF (Cellcept) and Steroids
Tacrolimus (Prograf)

Countries

Germany

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

Jun 2009

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

Mar 2002

Primary Completion Date

Jul 2006Actual

Completion Date

Oct 2008Actual

First Submitted Date

Jun 1, 2009

First Submission Date that Met QC Criteria

Jun 2, 2009

First Posted Date

Jun 3, 2009Estimated

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

Jun 2, 2009

Last Update Posted Date

Jun 3, 2009Estimated

Name	Class
Astellas Pharma GmbH	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

Description Module

Brief Summary

Kidney transplantation in the elderly is a challenge since patient's co-morbidity and the decreased injury threshold of older grafts may limit the benefits of transplantation in these patients. To compare favourable effects between low dose tacrolimus (LD-Tac) and mycophenolate-mofetil (MMF) in this patient population the investigators conducted a one year prospective multicenter randomized controlled trial. 90 kidney transplant recipients > 65 years with cadaveric grafts (> 65 years) from 5 centers were enrolled and received baseline immunosuppression with daclizumab induction (1 mg/kg) at day one and day 14, LD-Tac (trough level 5-8 µg/ml), MMF (1-2 g/d) and steroids. After three months, patients were centrally randomized either to MMF (1-2 g/d) and steroids (23 patients) or to LD-Tac and steroids. Follow-up visits were performed every 4 weeks up to one year. Protocol biopsies were performed after one year. The investigators' primary hypothesis is that the biopsy proven rejection rate in the MMF group is not significantly different compared to the LD-Tac group after one year. The investigators' secondary hypothesis is that graft function in the MMF group (reflected by the glomerular filtration rate and protocol biopsy result) is superior to the graft function in the LD-Tac group.

Detailed Description

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

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MMF and Steroid Group	Active Comparator	Group of Patients randomized to MMF and Steroid maintenance immunosuppression after 3 months (Tacrolimus withdrawal)	Drug: MMF (Cellcept) and Steroids
Low-Dose Tacrolimus Group	Active Comparator	Patients randomized to withdrawal of MMF after 3 months and maintenance immunosuppression with low-dose tacrolimus and Steroids	Drug: Tacrolimus (Prograf)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MMF (Cellcept) and Steroids	Drug	Prograf was withdrawn completely after randomization, MMF and steroids were given.	MMF and Steroid Group

Measure	Description	Time Frame
Acute rejection rate		One year

Measure	Description	Time Frame
Graft function		One year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients receiving a cadaveric kidney transplant (first or re-transplant)
Patients must met the criteria of the EUROTRANSPLANT program
Organ allocation with the framework of EUROPEAN SENIOR PROGRAM (ESP) by EUROTRANSPLANT
Written consent

Exclusion Criteria:

Not fulfilled inclusion criteria
Cadaveric kidney from "non heart beating donors"
One or more than one steroid resistant acute rejections within the first 3 weeks after transplantation
Two or more than two steroid sensitive rejections (more than 2 administered steroid boli) within the first 3 weeks after transplantation
Tacrolimus trough level > 10ng/ml in three consecutive measurements
Allergy against macrolide antibiotics or tacrolimus
Systemic steroid therapy at study entry not related to transplantation
History of Malignancy
Clinical relevant uncontrolled infections, heavy diarrhea, vomiting or active ulcer disease
Patients who are enrolled in other clinical studies or were enrolled in other clinical studies 28 days before transplantation
Patients under medication not approved by the German Ministry of Health

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lutz Fricke, MD, PhD	University of Luebeck	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Transplant Center Cologne (Koeln-Mehrheim)		Cologne	Cologne	51109	Germany
University of Essen - Transplant Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9428817	Background	Vincenti F, Kirkman R, Light S, Bumgardner G, Pescovitz M, Halloran P, Neylan J, Wilkinson A, Ekberg H, Gaston R, Backman L, Burdick J. Interleukin-2-receptor blockade with daclizumab to prevent acute rejection in renal transplantation. Daclizumab Triple Therapy Study Group. N Engl J Med. 1998 Jan 15;338(3):161-5. doi: 10.1056/NEJM199801153380304.
12221456

ID	Term
D009173	Mycophenolic Acid
D013256	Steroids
D016559	Tacrolimus

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals