PKD Clinical and Translational Core Study

Polycystic Kidney Disease Clinical Trial

Official title:

The Baltimore Polycystic Kidney Disease Clinical and Translational Core Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01873235
• Other study ID #: HP-00054815; 5P30DK090868-02
• Secondary ID: 5P30DK090868
• Status: Recruiting
• Start date: March 2013
• Est. completion date: June 2026

Study information

• Verified date: August 2023
• Source: University of Maryland, Baltimore
• Contact: Charalett E Diggs, RN, MSN
• Phone: 410-706-2122
• Email: charalett.diggs[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The purpose of this study is to establish a prospective observational cohort of 350 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Polycystic Kidney Disease
• Polycystic Kidney Diseases

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine General Clinical Research Center	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospitalizations	Self- reported Hospitalizations with medical record retrieval for verification	Annually up to 8 Year follow up to assess changes between time points
Primary	Renal volume by MRI	Calculations of the volume will be based on summation of the products of the area measurements of the kidneys and/or liver and slice thickness. A region-based signal threshold method will be applied to calculate total cyst volume, and the remaining parenchymal renal and hepatic volume.	Baseline and 3 Year follow up measures to assess changes between the time points
Secondary	Quality of Life Instruments	Self-reported Quality of Life (pain, anxiety, depression, physical activity, fatigue).	Annually up to 3 Year follow up measures to assess changes between the time points

External Links

•   Baltimore PKD Core Center