Rare Kidney Stone Consortium Patient Registry

Primary Hyperoxaluria Clinical Trial

— RKSC  

Official title:

Rare Kidney Stone Consortium Registry for Hereditary Kidney Stone Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00588562
• Other study ID #: 11-001702
• Secondary ID: 1U54DK083908-01
• Status: Recruiting
• Start date: July 2003
• Est. completion date: June 2025

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: Julie B. Olson, RN
• Phone: 507-538-5995
• Email: rarekidneystones[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect medical information from a large number of patients in many areas of the world with primary hyperoxaluria (PH), Dent disease, Cystinuria and APRT deficiency. This information will create a registry that will help us to compare similarities and differences in patients and their symptoms. The more patients we are able to enter into the registry, the more we will be able to understand the Primary Hyperoxalurias,Dent disease, cystinuria and APRT and learn better ways of caring for patients with these diseases.

Description:

This study involves the collection of medical information to create a computer database or registry for patients with PH, Dent disease, cystinuria and APRT deficiency. The information will be entered into the registry by your physician or health care provider. The computer web site for the registry is secure and protected by a required password. Some information which will be entered may include your age at first symptoms of PH,Dent disease, cystinuria or APRT, laboratory values, kidney function and the progress of your health over time. Information for an individual patient can only be viewed by the appropriate physician or staff. Once the information is entered into the registry, you will only be identified by a code number.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 730
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 100 Years

Eligibility

Inclusion Criteria:

• Individuals must have a definitive diagnosis of Primary Hyperoxaluria, Dent Disease, Cystinuria or APRT Deficiency.
• Individuals have a family history of a sibling with Primary Hyperoxaluria,Dent Disease, Cystinuria or APRT Deficiency.

Exclusion Criteria:

• Individuals who do not have Primary Hyperoxaluria, Dent Disease, Cystinuria or APRT Deficiency.

Related Conditions & MeSH terms

• APRT Deficiency
• Cystinuria
• Dent Disease
• Hyperoxaluria, Primary
• Kidney Calculi
• Nephrolithiasis
• Primary Hyperoxaluria

Locations

Country	Name	City	State
Iceland	APRT Registry - Landspitali Universtiy Hospital	Reykjavik
United States	Cystinuria Registry - New York University	New York	New York
United States	Dent Disease Registry -Mayo Clinic	Rochester	Minnesota
United States	Primary Hyperoxaluria Registry - Mayo Clinic	Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Oxalosis and Hyperoxaluria Foundation (OHF)

Countries where clinical trial is conducted

United States,  Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish and expand registries and collaborate with patient organizations for the rapid dissemination of knowledge	The patient Registries will expand knowledge of the clinical expression of these disease by systematically accumulating and analyzing information regarding a larger number of patients than have been studied to date.	Yearly
Secondary	Improved understanding of symptoms and progression of four major diseases of hereditary nephrolithiasis.	The goal of the patient Registries is to collect data about these rare diseases, provide a better understanding of these four conditions and help to develop new treatments.	Yearly

External Links

•   Mayo Clinic Clinical Trials