Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT01632605
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01632605
Study Brief:
Protocol Section:
NCT01632605