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IDENTIFICATION OF A MULTI-ANALYTE PROFILE FOR PRIMARY HYPEROXALURIA AND COMPARISON WITH HEALTHY SIBLINGS AND IDIOPATHIC HYPERCALCIURIA (PH1)

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ClinicalTrials.gov Identifier: NCT02830009
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

The aim of this study is to know the difference between protein profiles (multi-analyte profile) of PH1 patients, idiopathic hypercalciuria (IH) patients and PH1 patients 'siblings. Idiopathic hypercalciuria is a less severe kidney disease that PH1, which also leads to the formation of kidney stones.

The aim is to identify patterns of discriminating markers associated with primary hyperoxaluria type 1 (PH1) that will significantly improve clinical diagnosis and prognosis.


Condition or disease Intervention/treatment Phase
Primary Hyperoxaluria Type 1 Idiopathic Hypercalciuria Other: Urines samples Other: Blood sample Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : May 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Primary Hyperoxaluria patient Other: Urines samples
24-hour urines will be collected
Other: Blood sample
Primary Hyperoxaluria patient's siblings Other: Urines samples
24-hour urines will be collected
Other: Blood sample
Idiopathic hypercalciuria patients Other: Urines samples
24-hour urines will be collected
Other: Blood sample
Healthy volunteers Other: Urines samples
24-hour urines will be collected
Other: Blood sample



Primary Outcome Measures :
  1. presence of protein markers in urine [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Presence of discriminative and robust protein markers in urine [ Time Frame: 24 hours ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosed with primary hyperoxaluria, type 1 (PH1-Cohort A); OR
  • Confirmed with AGXT mutation analysis (PH1-Cohort A)
  • Diagnosed with idiopathic hypercalciuria (IHC- Cohort B);
  • Potential subject diagnosed with PH1 or IH and has both data entered into the registry and has matched, archived random and 24-hour urine specimens obtained prior to any treatment intervention OR is consented and enrolled into the registry or this specific study during the program;
  • Healthy siblings of PH1 patients known not to have PH or any another stone disease or chronic disease will be consented and enrolled into this study through the local sites where their sibling is being treated for PH1 (this study meets the criteria for expedited review through local or central IRBs);
  • Healthy non-sibling controls known not to have PH or any another stone disease or chronic disease (Healthy Control-Cohort C);
  • There is no upper or lower limit to the pediatric age range of enrolling infant, children and adolescent subjects, although it is understood that accurate and complete 24-hour urine collection in very young children and infants will be problematic and will be seriously considered in advance of individual patient or healthy controls enrollment;
  • eGFR (Glomerular Filtration Rate) > 60 mL/min x 1.73 m2 with PH1 and IH patient cohorts matched by mean eGFR from their initial study (or registry) enrollment/ data collection.

Exclusion Criteria:

  • Unwilling to provide written parent consent or adolescent assent to enroll into the International Registry or this study;
  • Potential PH1, hypercalciuria, or siblings of PH1 patients with other chronic or acute illness or disease that could potentially confound proteomic results;
  • Healthy intra-familial siblings unwilling to provide a blood sample for serum creatinine;
  • Unwilling to provide urine specimens or permit data abstraction for the registry or this study.
  • Not covered by, or having the right to, Social Security

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830009


Locations
France
Hospices Civils de Lyon
Lyon/bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02830009     History of Changes
Other Study ID Numbers: 2010-604
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hyperoxaluria, Primary
Hypercalciuria
Hyperoxaluria
Kidney Diseases
Urologic Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Urological Manifestations
Signs and Symptoms