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Trial record 16 of 19 for:    "Cystinuria"

Prospective Research Rare Kidney Stones (ProRKS) (ProRKS)

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ClinicalTrials.gov Identifier: NCT02780297
Recruitment Status : Recruiting
First Posted : May 23, 2016
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
John Lieske, Mayo Clinic

Tracking Information
First Submitted Date May 11, 2016
First Posted Date May 23, 2016
Last Update Posted Date November 10, 2020
Study Start Date May 2016
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 19, 2016)
inflammatory blood and urinary biomarkers [ Time Frame: Annually for 5 years ]
Statistically significant changes (increase or decrease) in inflammatory urinary biomarkers compared to reference values
Original Primary Outcome Measures
 (submitted: May 20, 2016)
inflammatory blood and urinary biomarkers [ Time Frame: Baseline to 5 years ]
Change History
Current Secondary Outcome Measures
 (submitted: September 19, 2016)
Longitudinal changes in eGFR [ Time Frame: Annually for 5 years ]
changes in eGFR during the 5 years
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: September 19, 2016)
  • Development of new onset CKD [ Time Frame: Annually for 5 years ]
    Development of new onset CKD stage 4 (eGFR<30) or stage 5 (eGFR<15)
  • Lithogenic substances in the urine [ Time Frame: Annually for 5 years ]
    Quantity of change in the substance in the urine
  • Protein in the urine [ Time Frame: Annually for 5 years ]
    change in protein in the urine
  • Stone events [ Time Frame: Annually for 5 years ]
    change in number of stone events
  • Quality of Life [ Time Frame: Annually for 5 years ]
    change in the quality of life score
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Research Rare Kidney Stones (ProRKS)
Official Title Prospective Research Rare Kidney Stones (ProRKS)
Brief Summary The purpose of this study is to determine the natural history of the hereditary forms of nephrolithiasis and chronic kidney disease (CKD), primary hyperoxaluria (PH), cystinuria, Dent disease and adenine phosphoribosyltransferase deficiency (APRTd) and acquired enteric hyperoxaluria (EH). The investigator will measure blood and urinary markers of inflammation and determine relationship to the disease course. Cross-comparisons among the disorders will allow us to better evaluate mechanisms of renal dysfunction in these disorders.
Detailed Description Severe, hereditary forms of nephrolithiasis cause marked excretion of insoluble minerals important in stone formation, including primary hyperoxaluria, cystinuria, Dent disease, and adenine phosphoribosyltransferase deficiency (APRTd). Patients with these disorders experience recurring stones from childhood and are at high risk for chronic kidney disease caused by crystal nephropathy. Enteric hyperoxaluria is an acquired disease characterized by hyperoxaluria and calcium oxalate crystal nephropathy associated with chronic kidney disease, and in that respect similar to the inherited stone diseases. The investigators will collect longitudinal data of individual patients in order to provide clues about potentially modifiable factors that influence disease severity and identify factors leading to kidney injury. the investigator will measure blood and urinary markers of inflammation and determine relationship to the disease course. Cross-comparisons among the disorders will allow to better evaluate mechanisms of renal dysfunction in these diseases.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals with Primary Hyperoxaluria, Dent Disease, Cystinuria and APRT Deficiency, Lowe syndrome, Dent Disease Carriers and Enteric Hyperoxaluria
Condition
  • Hyperoxaluria
  • Cystinuria
  • Dent Disease
  • Lowe Syndrome
  • Adenine Phosphoribosyltransferase Deficiency
Intervention Not Provided
Study Groups/Cohorts
  • Primary Hyperoxaluria Patients
    Patients with confirmed diagnosis of Primary Hyperoxaluria.
  • Dent Disease Patients
    Patients with confirmed diagnosis of Dent Disease.
  • Cystinuria Patients
    Patients with confirmed diagnosis of Cystinuria.
  • APRT deficiency Patients
    Patients with confirmed diagnosis of adenine phosphoribosyltransferase deficiency (APRTd)
  • Lowe Syndrome or Dent 2 patients
    Patients with confirmed diagnosis of Lowe Syndrome or Dent 2.
  • Dent 1 carriers
    Patients with confirmed diagnosis of Dent 1. Dent 1 carriers
  • Enteric Hyperoxaluria Patients
    Patients with confirmed diagnosis enteric hyperoxaluria.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 20, 2016)
220
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2024
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Diagnosis of primary hyperoxaluria
  2. Diagnosis of enteric hyperoxaluria
  3. Diagnosis of Dent Disease
  4. Diagnosis of Cystinuria
  5. Diagnosis of adenine phosphoribosyltransferase deficiency (APRTd)
  6. Diagnosis of Lowe Syndrome
  7. Diagnosis of Dent Disease Carrier

Exclusion Criteria:

  1. Prior renal failure
  2. History of liver and/or kidney transplant.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Barb Seide 800-270-4637 RareKidneyStones@mayo.edu
Contact: Julie Olson, RN 800-270-4637 RareKidneyStones@mayo.edu
Listed Location Countries Canada,   Iceland,   Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02780297
Other Study ID Numbers 16-000494
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party John Lieske, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators
Principal Investigator: John Lieske, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date November 2020