NCT00123331

Brief Summary

Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. Current therapeutic approaches include cyclosporine reduction or discontinuation. It is unclear whether discontinuation of low dose cyclosporine also has a beneficial effect, i.e. is there a threshold effect for cyclosporine nephrotoxicity? Study Design: Heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a) no change; or b) discontinuation of cyclosporine and initiation of rapamycin immunosuppression. Read-Out: Renal function after 6 months; tolerability; and safety were assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2003

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

October 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
Last Updated

August 2, 2005

Status Verified

June 1, 2005

First QC Date

July 18, 2005

Last Update Submit

August 1, 2005

Conditions

Heart TransplantationRenal Failure

Keywords

Heart transplantationRenal failureCyclosporineRapamycin

Outcome Measures

Primary Outcomes (1)

  • Renal function after 6 months (serum creatinine, calculated creatinine clearance)

Secondary Outcomes (4)

  • Survival

  • Rejection (clinical)

  • Tolerability

  • Blood pressure

Interventions

Cyclosporine discontinuationDRUG
Rapamycin medicationDRUG

Eligibility Criteria

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

You may qualify if:

  • Heart transplantation (\> 6 months post-operation)
  • Renal failure (serum creatinine stably \> 1.7 mg/dl
  • Cyclosporine trough blood level \< 110 ng/ml

You may not qualify if:

  • \< 18 years of age
  • Rapamycin intolerability
  • Active infection
  • Pregnancy, breast feeding
  • Major elective surgery planned in study period
  • Thrombopenia \< 100,000/ml

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Universitätsklinik, Kardiologie

Heidelberg, D-69115, Germany

Location

Related Publications (1)

  • Angermann CE, Stork S, Costard-Jackle A, Dengler TJ, Siebert U, Tenderich G, Rahmel A, Schwarz ER, Nagele H, Wagner FM, Haaff B, Pethig K. Reduction of cyclosporine after introduction of mycophenolate mofetil improves chronic renal dysfunction in heart transplant recipients--the IMPROVED multi-centre study. Eur Heart J. 2004 Sep;25(18):1626-34. doi: 10.1016/j.ehj.2004.06.032.

    PMID: 15351162BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Thomas J Dengler, MD

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2005

First Posted

July 22, 2005

Study Start

October 1, 2003

Study Completion

April 1, 2005

Last Updated

August 2, 2005

Record last verified: 2005-06

Locations

DE(1)