NCT00359814

Brief Summary

The purpose of this study is to improve or save renal function by optimizing the immunosuppressive regimen by reducing the Cyclosporine A dose and the exchange of Azathioprine by Mycophenolatmofetile, which is an effective immunosuppressive agent and will minimize the risk of acute rejection episodes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 16, 2009

Status Verified

February 1, 2009

Enrollment Period

3.6 years

First QC Date

August 1, 2006

Last Update Submit

February 13, 2009

Conditions

Heart Transplantation

Keywords

Cyclosporinerenal insufficiency, chroniclong-term care

Outcome Measures

Primary Outcomes (1)

  • Renal function evaluated by serum creatinine at month 12 and month 24

    month 12 and month 24

Secondary Outcomes (3)

  • acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24

    month 12 and month 24

  • Cardiovascular risk factors at month 12 and month 24

    month 12 and month 24

  • Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24

    month 12 and month 24

Study Arms (1)

1

EXPERIMENTAL

Azathioprine administration: was stopped at day 0; Mycophenolatmofetile administration: was started with 250 mg/daily at day 1, the start dose was increased about 250 mg/daily every week till 2 g/daily; Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml

Drug: MycophenolatmofetileDrug: Cyclosporin A

Interventions

MycophenolatmofetileDRUG

Mycophenolatmofetile administration: was started with 250 mg/daily at day 1, the start dose was increased about 250 mg/daily every week till 2 g/daily

Also known as: MMF, CellCept
1
Cyclosporin ADRUG

Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml

Also known as: Sandimmun optoral
1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current immunosuppressive regimen: Cyclosporine A, Azathioprine and corticosteroids for at least 12 month
  • Heart transplantation above 3 years dated back
  • Serum creatinine \< 3,5 mg/dl (310 µmol/l) and BUN \< 150 mg/dl
  • Cyclosporine A blood level between 50 and 250 ng/ml during the last 12 month

You may not qualify if:

  • Carcinoma within the last 3 years
  • Acute rejection episodes during the last 6 month
  • Infection requiring therapeutic intervention
  • Hepatitis B, Hepatitis C or HIV infection
  • WBC \< 3000/µl, haemoglobin \< 9g/dl, platelets \< 70.000/µl
  • Florid gastrointestinal ulcer
  • Haemodialysis within the last 4 weeks before study entry
  • Pregnancy / lactation
  • Administration of other immunosuppressive agents than prescribed
  • Mycophenolatmofetile incompatibility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School, Department of Thoracic and Cardiovascular Surgery

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Mycophenolic AcidCyclosporine

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Christoph Bara, Dr. med.

    Hannover Medical School, Department of Thoracic and Cardiovascular Surgery

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2006

First Posted

August 2, 2006

Study Start

November 1, 2004

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 16, 2009

Record last verified: 2009-02

Locations

DE(1)