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:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT01873235
Eligibility Criteria:
Inclusion criteria:
* Age 18 and older
* ADPKD confirmed by genetic testing or ultrasound criteria using modified Ravine criteria: with family history:several cysts per kidney (3 by sonography, 5 if by computerized tomography or MRI)without family history: 10 cysts (by any radiologic method) per kidney and exclusion of other cystic kidney diseases
* Ability to provide written informed consent prior to initiation of any study procedures and the ability in the opinion of the investigator to comply with all requirements of the study
* Glomerular Filtration Rate (GFR) greater than 15ml/min/1.73m2
Exclusion Criteria:
* End Stage Renal Disease or presently on dialysis or a prior kidney transplant
--Pregnant, lactating, or intention to get pregnant in next 6 weeks
* Another systemic disease such as cancer or lupus
* Life expectancy less than 2 years
* Current participation in a drug treatment trial
* Non English speaking
* Uncontrolled diabetes A1C 7.0 or more within 6 months of study visit; and/or on more than one oral hypoglycemic agent
* Diabetic nephropathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01873235
Study Brief:
Protocol Section:
NCT01873235