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CompletedNCT02830009PH1Updated Jul 13, 2016

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

An interventional study of Urines samples and Blood sample in Primary Hyperoxaluria Type 1 and Idiopathic Hypercalciuria, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2016-07-13.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Non-randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Hyperoxaluria Type 1
  • Idiopathic Hypercalciuria
03

In context

Primary hyperoxaluria type 1

22 studies on the registry are indexed under Primary hyperoxaluria type 1; 8 are open to participants now.

This study's enrollment of 5 is below the median of 28 across 16 interventional studies indexed under Primary hyperoxaluria type 1.

Browse Primary hyperoxaluria type 1 studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Browse Hospices Civils de Lyon studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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;
  • (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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Other
    Primary Hyperoxaluria patient

    Other: Urines samples · Other: Blood sample

  • Other
    Primary Hyperoxaluria patient's siblings

    Other: Urines samples · Other: Blood sample

  • Other
    Idiopathic hypercalciuria patients

    Other: Urines samples · Other: Blood sample

  • Other
    Healthy volunteers

    Other: Urines samples · Other: Blood sample

Interventions

  • OtherUrines samples

    24-hour urines will be collected

  • OtherBlood sample
06

What researchers measure

Primary outcomes

  1. presence of protein markers in urine

    Time frame: 24 hours

Secondary outcomes

  1. Presence of discriminative and robust protein markers in urine

    Time frame: 24 hours

07

Study locations

1 site
  • Hospices Civils de Lyon
    Lyon/bron, 69500, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2013, a primary completion of Jul 2013 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2016
First posted
Jul 12, 2016
Start
May 2013
Primary completionActual
Jul 2013
CompletionActual
Dec 2015
Last update
Jul 13, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02830009
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Jul 12, 2016
Start date
May 2013
Primary completion
Jul 2013
Completion
Dec 2015
Last update
Jul 13, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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