PKD Clinical and Translational Core Study
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 2013 |
| End Date: | June 2020 |
| Contact: | Charalett E Diggs, RN, MSN |
| Email: | cdiggs@medicine.umaryland.edu |
| Phone: | 410-328-0207 |
The Baltimore Polycystic Kidney Disease Clinical and Translational Core Study
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=200) 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.
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=200) 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.
The purpose of this study is to establish a prospective observational cohort of 200
well-characterized adults with ADPKD, and an associated biorepository of DNA, plasma, serum,
and urine. Baseline clinical phenotyping includes measurement of renal filtration function,
total kidney volume, clinical and family history, presence and history of renal and
extra-renal ADPKD manifestations, cardiac function, vascular stiffness, and health-related
quality of life.
Prospective characterization will include the development of ADPKD complications (e.g.,
infection, stones, cyst hemorrhage) and other acute medical events, and changes in symptoms
and QoL.
In addition, an electronic PKD patient registry will collect demographic and contact
information on adults with ADPKD interested in participating in future clinical trials and/or
observational cohort studies.
No treatment interventions will be performed in these observational studies
well-characterized adults with ADPKD, and an associated biorepository of DNA, plasma, serum,
and urine. Baseline clinical phenotyping includes measurement of renal filtration function,
total kidney volume, clinical and family history, presence and history of renal and
extra-renal ADPKD manifestations, cardiac function, vascular stiffness, and health-related
quality of life.
Prospective characterization will include the development of ADPKD complications (e.g.,
infection, stones, cyst hemorrhage) and other acute medical events, and changes in symptoms
and QoL.
In addition, an electronic PKD patient registry will collect demographic and contact
information on adults with ADPKD interested in participating in future clinical trials and/or
observational cohort studies.
No treatment interventions will be performed in these observational studies
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
We found this trial at
1
site
Baltimore, Maryland 21201
Principal Investigator: Terry Watnick, MD
Phone: 410-328-0207
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