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Clinical Trials/NCT02522338
NCT02522338
Completed
Phase 4

Measurement of Glomerular Filtration Rate (GFR) in HIV Patients: Single-center Study Comparing the Accuracy of Estimators of GFR Versus Iohexol Plasma Clearance

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country300 target enrollmentFebruary 2011
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ConditionsHIV
Interventionsiohexol
Drugsiohexol

Overview

Phase
Phase 4
Intervention
iohexol
Conditions
HIV
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
300
Locations
1
Primary Endpoint
Patient with a predictive performance range -30% to +30%
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

Cystatin C, a protease inhibitor produced by most nucleated cells, is freely filtered by the kidneys, and its plasma assay reflects the GFR.

Compare, in HIV patients, the predictive performance of 11 formula to estimate GFR based on assay plasma cystatin C with that of the MDRD formulas.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
December 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Patients infected with HIV, and included in the cohort NADIS

Exclusion Criteria

  • •Patient with a known allergy
  • •Patients treated with metformin
  • •Patients with severe hepatic impairment defined as a TP spontaneously below 50%
  • •Patients with a history of dysthyroidism
  • •Patient with active neoplasia other than skin cancer
  • •Degradation recent (not older than 3 months) in renal function defined as the deterioration of GFR over 25%.
  • •Estimated GFR less than 15 mL/min/1, 73m2
  • •Pregnant or lactating
  • •Subjects under the protection of justice

Arms & Interventions

iohexol plasma clearance

patients had received iohexol for measuring GFR

Intervention: iohexol

Outcomes

Primary Outcomes

Patient with a predictive performance range -30% to +30%

Time Frame: day 0

for each estimator :predictive performance calculated by \[(DFG estimé\* - DFG mesuré par iohexol\*\*)/DFG mesuré par iohexol\]X100

Study Sites (1)

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