NCT01873235 PKD Clinical and Translational Core Study
| NCT ID | NCT01873235 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | Polycystic Kidney Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2013-03 |
| Primary Completion | 2030-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2013-03 with a primary completion date of 2030-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Advances in our understanding of the pathogenesis of autosomal dominant polycystic kidney disease (ADPKD) have opened up possibilities of new therapies to prevent disease progression. High quality clinical investigations in patients with ADPKD, however, pose significant challenges to investigators including limited access to patients with ADPKD,insufficient guidance by experienced investigators and lack of resources to conduct these studies. The Polycystic Kidney Disease Research Clinical and Translational Core (P30) aims to establish an infrastructure that will assist investigators in designing and conducting highest quality clinical and translational research focused on a diverse group of patients with ADPKD. Objective 1: To establish a Mid-Atlantic cohort of ADPKD patients (N=350) with baseline clinical phenotyping performed at the General Clinical Research Unit of the University of Maryland School of Medicine. Objective 2: To establish a state-of-the-art biobank of specimens from the ADPKD cohort including serum, plasma,urine and DNA. Objective 3: To develop a collaborative network of physicians and practices in the Mid-Atlantic region who will contribute to the ADPKD cohort and will be willing to refer patients for future studies and trials. Objective 4: To establish a web-based registry of ADPKD patients in the Mid-Atlantic area.
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
Contact & Investigator
Terry J Watnick, MD
PRINCIPAL INVESTIGATOR
University of Maryland, Baltimore
Frequently Asked Questions
Who can join the NCT01873235 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Polycystic Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01873235 currently recruiting?
Yes, NCT01873235 is actively recruiting participants. Contact the research team at charalett.diggs@som.umaryland.edu for enrollment information.
Where is the NCT01873235 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT01873235 clinical trial?
NCT01873235 is sponsored by University of Maryland, Baltimore. The principal investigator is Terry J Watnick, MD at University of Maryland, Baltimore. The trial plans to enroll 350 participants.
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