NCT01873235Recruiting
PKD Clinical and Translational Core Study
The Baltimore Polycystic Kidney Disease Clinical and Translational Core Study
Source: ClinicalTrials.gov · Last updated 11 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 350 (estimated)
- First submitted
- 23 May 2013
- Start date
- Mar 2013
- Primary completion date
- Jun 2030
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Polycystic kidney disease
- NCT number
- NCT01873235
What you commit to
- Study type: Observational
- Planned participants: 350
- From Mar 2013 to the primary completion date, Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- End Stage Renal Disease or presently on dialysis or a prior kidney transplant
- --Pregnant, lactating, or intention to get pregnant in next 6 weeks
- Current participation in a drug treatment trial
Other illness
- Another systemic disease such as cancer or lupus
- Uncontrolled diabetes A1C 7.0 or more within 6 months of study visit; and/or on more than one oral hypoglycemic agent
Other
- Life expectancy less than 2 years
- Non English speaking
- Diabetic nephropathy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Maryland School of Medicine General Clinical Research Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.