NCT00139035

Brief Summary

Our primary aim is to investigate if cyclosporine A reduces insulin secretion.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4

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

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Last Updated

November 2, 2012

Status Verified

October 1, 2012

Enrollment Period

9 months

First QC Date

August 29, 2005

Last Update Submit

October 31, 2012

Conditions

Chronic Renal Failure

Keywords

glucose intoleranceinsulinmicrovascular functiongenotypingCYP3A5pharmacokineticsrenal transplantation

Outcome Measures

Primary Outcomes (1)

  • Insulin secretion

Secondary Outcomes (3)

  • Peripheral insulin sensitivity

  • Endothelial function

  • Pharmacokinetics

Interventions

cyclosporine ADRUG

Eligibility Criteria

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

You may qualify if:

  • Renal failure patients on dialysis which is planned to receive a renal transplant

You may not qualify if:

  • Age below 18 years or above 75 years
  • Pregnancy
  • Breast feeding mothers
  • Diabetes mellitus /WHO criteria)
  • Dialysis treatment less than 2 months
  • Serious coronary heart disease
  • Unstable angina pectoris
  • Recent acute infarction (less than 3 months)
  • Non-compensated heart failure
  • Simultaneous treatment with glucocorticosteroids (e.g. prednisolone, dexamethasone), diltiazem, verapamil, erythromycin, clarithromycin, telithromycin, rifampicin, fluconazole, itraconazole, ketoconazole, voriconazole, indinavir, nelfinavir, ritonavir, nefazodone, bosentan, carbamazepine, St. John's worth, grapefruit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet, Section of Nephrology

Oslo, Oslo County, 0027, Norway

Location

MeSH Terms

Conditions

Kidney Failure, ChronicGlucose IntoleranceInsulin Resistance

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Anders Åsberg, MSc

    University of Oslo

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

April 1, 2005

Primary Completion

January 1, 2006

Last Updated

November 2, 2012

Record last verified: 2012-10

Locations

NO(1)