Overview
The Vienna RAP Pilot Study
Status:
Completed
Completed
Trial end date:
2012-04-01
2012-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the safety of a daily single oral dose of sirolimus in patients with advanced autosomal dominant polycystic kidney disease.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Medical University of ViennaTreatments:
Everolimus
Sirolimus
Criteria
Inclusion Criteria:- ADPKD
- Eighteen years of age, or older.
- Baseline eGFR of 20-40mL/min per 1.73m2.
- Negative serum pregnancy test prior to administration of sirolimus and agreement to
use contraception throughout the pilot safety study and three months after. Any
participant who is getting pregnant during the pilot safety study period will have to
discontinue.
- Written informed consent.
Exclusion Criteria:
- Pregnancy or lactation or plans to become pregnant in the near future or disagreement
to use contraception.
- History of life threatening complications of ADPKD.
- Evidence of active systemic- or localized major infection.
- Evidence of infiltrate, cavities or consolidation on chest X-ray.
- Use of any investigational drug or -treatment up to 4 weeks prior to the enrolment and
during the pilot safety study.
- Known hypersensitivity to sirolimus and its derivatives.
- Treatment with substances known to interfere with the cytochrome p-450 (CYP) 3A4/3A5
systems.
- Screening/baseline total white blood cell count below or equal to 3000/mm3.
- Screening/baseline platelet count below or equal to 100.000/mm3.
- Screening/baseline fasting triglycerides above or equal to 400 mg/dL.
- Screening/baseline fasting total cholesterol above or equal to 300 mg/dL.
- Concomitant glomerular diseases.
- Psychiatric disorders or any condition that might prevent the full comprehension of
the purposes and risks of the pilot safety study.
- History of malignancies with the exception of adequately treated basal- and
squamous-cell carcinomas of the skin.
- HIV infection.