Suspended

VELDONDesensitization With Bortezomib Before a Living Kidney Donation

What is being tested

Bortezomib

Drug

Who is being recruted

From 18 to 70 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: March 2013

See protocol details

Summary

Principal SponsorAssistance Publique - Hôpitaux de Paris

Study ContactHélène François, MD, PhDMore contacts

Last updated: September 29, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

The investigators plan to study the role of bortezomib for desensitizing patients awaiting a living kidney donation who have a titer of Donor Specific anti HLA Antibody (DSA) between 1000 and 3000 MFI with a multicentre pilot study of 10 patients. The effect of bortezomib will be observed up to 6 month after bortezomib treatment prior to transplantation and 12 month after transplantation if performed. The living kidney donation will be performed only if the DSA level drops below 1000 MFI which means an efficacy of the desensitization.

NCT01842074

Principal SponsorAssistance Publique - Hôpitaux de Paris

Study ContactHélène François, MD, PhDMore contacts

Last updated: September 29, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate

Patient between 18 and 70 years old

awaiting a living kidney donation

but with a least one DSA titer between 1000 MFI and 3000 MFI

3 exclusion criteria prevent from participating

DSA level above 3000 MFI

and every condition that is a contre indication for bortezomib treatment

positive cell dependent cytotoxicity CM

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital

Le Kremlin-Bicêtre, FranceOpen Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital in Google Maps

SuspendedOne Study Center