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

HIV Clinical Trial

— HIVOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522338
• Other study ID #: 1008078
• Secondary ID: 2010-022272-31
• Status: Completed
• Phase: Phase 4
• First received: August 4, 2015
• Last updated: March 9, 2016
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• iohexol
10 ml de l'iohexol (300 mgI/ml)

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient with a predictive performance range -30% to +30%	for each estimator :predictive performance calculated by [(DFG estimé* - DFG mesuré par iohexol**)/DFG mesuré par iohexol]X100	day 0	No