NCT02522338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4 hiv

Timeline
Completed

Started Feb 2011

Typical duration for phase_4 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

2.8 years

First QC Date

August 4, 2015

Last Update Submit

March 9, 2016

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

iohexol plasma clearance

OTHER

patients had received iohexol for measuring GFR

Drug: iohexol

Interventions

iohexolDRUG

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

iohexol plasma clearance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Interventions

Iohexol

Intervention Hierarchy (Ancestors)

Triiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Frédéric LUCHT, MD PhD

    CHU de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 13, 2015

Study Start

February 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 10, 2016

Record last verified: 2016-03

Locations

FR(1)