Observational study on Polycystic Kidney Disease
The Baltimore Polycystic Kidney Disease Clinical and Translational Core Study
This study is trying to learn more about autosomal dominant polycystic kidney disease by gathering information from 350 adults to improve understanding of the disease and its effects on health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT01873235 on ClinicalTrials.gov |
What this trial studies
This study aims to establish a cohort of 350 adults with autosomal dominant polycystic kidney disease (ADPKD) to enhance understanding of the disease and its complications. Participants will undergo comprehensive clinical phenotyping, including assessments of kidney function, total kidney volume, and health-related quality of life. Additionally, a biobank will be created to store biological specimens for future research. The study will also develop an electronic registry for ADPKD patients interested in future clinical trials.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of ADPKD and a glomerular filtration rate greater than 15 ml/min/1.73m2.
Not a fit: Patients with end-stage renal disease, those currently on dialysis, or individuals with other significant systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of ADPKD, potentially informing future therapeutic strategies.
How similar studies have performed: While this study builds on existing knowledge of ADPKD, it employs a novel approach to establish a comprehensive cohort and biobank, which has not been extensively tested in this manner.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- University of Maryland School of Medicine General Clinical Research Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Terry J Watnick, MD — University of Maryland, Baltimore
- Study coordinator: Charalett E Diggs, RN, MSN
- Email: charalett.diggs@som.umaryland.edu
- Phone: 410-706-2122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.