The Vienna Prograf and Endothelial Progenitor Cell Study (Vienna PEP Study) - Vienna PEP Study

• Conditions: Kidney Transplantation

• Registration Number: EUCTR2004-004209-98-AT
• Lead Sponsor: Medical University Vienna, Department of Medicine III

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-11
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

1. Patient is recipient of a deceased or living donor renal transplant (including re-transplants)
2. Patient was =18 years of age at the time of transplantation.
3. Patient is at least 6 months post-transplant.
4. Patient is on a cyclosporine-based immunosuppression regimen in combination with/without MMF and/or steroids at study entry.
5. Patient has a functioning renal allograft and an estimated GFR =30 mL/min/1.73m2 within four weeks prior to study entry.
6. Patient has a stable graft function without biopsy proven acute rejection episode within 3 months prior to study entry.
7. Patient has not experienced a cardiovascular event (e.g. myocardial infarction, stroke, percutaneous angioplasty, bypass surgery,..) within 3 months prior to study entry.
8. Patient has been fully informed and has given written informed consent according to ICH-GCP. Patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed in writing by an independent person.
9. Females are not pregnant and agree to practice effective birth control while receiving immunosuppressant medication.
10. Patient has indications for conversion at the investigators discretion or is suffering from cyclosporine associated side effects like hypertension (=130 and/or =80 mm Hg, with or without antihypertensive therapy), hyperlipidemia (LDL-cholesterol = 100 mg/dl or triglycerides=200 mg/dl and non-HDL-cholesterol =130 mg/dl) or cosmetic side effects.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient is recipient of a solid organ transplant other than the kidney.
2. Patient has recurrence of primary renal disease, or de novo renal disease.
3. Patient is pregnant or lactating.
4. Patient had a known or suspected malignancy (except for treated squamous and basal cell skin cancers) <5 years before study entry or a history of post-transplant lymphoproliferative disease (PTLD).
5. Patient has known hypersensitivity to tacrolimus, or any of the recipients of the drug.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified