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

NCT ID: NCT02522338

Last Updated: 2016-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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iohexol plasma clearance

patients had received iohexol for measuring GFR

Group Type OTHER

iohexol

Intervention Type DRUG

10 ml de l'iohexol (300 mgI/ml)

Interventions

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iohexol

10 ml de l'iohexol (300 mgI/ml)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric LUCHT, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

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CHU de SAINT-ETIENNE

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2010-022272-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1008078

Identifier Type: -

Identifier Source: org_study_id

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