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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02830009
Other study ID # 2010-604
Secondary ID
Status Completed
Phase N/A
First received July 8, 2016
Last updated July 12, 2016
Start date May 2013
Est. completion date December 2015

Study information

Verified date July 2016
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date December 2015
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Other:
Urines samples
24-hour urines will be collected
Blood sample


Locations

Country Name City State
France Hospices Civils de Lyon Lyon/bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary presence of protein markers in urine 24 hours No
Secondary Presence of discriminative and robust protein markers in urine 24 hours No
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Terminated NCT02795325 - A Study of DCR-PH1 in Patients With Primary Hyperoxaluria Type 1 (PH1) Phase 1
Completed NCT03067142 - Proteomics of Primary Hyperoxaluria Type 1
Active, not recruiting NCT04152200 - A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1 Phase 3
Recruiting NCT05001269 - Nedosiran in Pediatric Patients From Birth to 11 Years of Age With PH and Relatively Intact Renal Function Phase 2
Recruiting NCT04982393 - BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1)
Not yet recruiting NCT06465472 - Evaluation of the Efficacy and Safety of Stiripentol in Patients 6 Years and Older With Primary Hyperoxaluria Type 1, 2 or 3 Phase 3
Recruiting NCT04580420 - Safety & Efficacy of DCR-PHXC in Patients With PH1/2 and ESRD Phase 2