Effect of Privigen Against Graft Loss

• Register: ClinicalTrials.gov
• Last refreshed on: 22 March 2021
• Main ID: NCT02374736
• Date of registration: 20/01/2015
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Effect of Privigen Against Graft Loss InAuGuRAL
• Scientific title: A Pilot Study on the Effect of Privigen Against Graft Loss: Interventional Study of Kidney Transplant Recipients at Risk for Graft Loss Through Antibody-mediated Rejection
• Date of first enrolment: February 5, 2016
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02374736
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Denis GLOTZ, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Deceased donor kidney transplant recipients between 3 and 12 months post
transplantation.

2. At least 18 years old.

3. With stable renal function assessed within 30 days before inclusion and with delta GFR
(MDRD) lower than 10 ml/min (latest result versus the average of the two previous
values).

4. Presence of at least one circulating HLA-DSA class I or II against HLA-A, -B, -DR,
-DQ, -DP, -C (MFI = 1000) as assessed by Luminex single antigen technique within 30
days before inclusion.

5. With histological markers of active antibody-mediated injury as defined by the
microcirculation inflammation score (g, ptc scores defined by current Banff criteria)
on protocol biopsies performed at M3 or M12 post-transplantation, or if required
between three and twelve months post transplantation (1 = g+ptc = 3).

6. Able to comply with the study procedures and follow the study instructions.

7. Who have read the information sheet and signed the informed consent form.

Exclusion Criteria:

1. Acute renal dysfunction at the time of enrolment: decrease of GFR higher or equal to
10 ml/min (latest result versus the average of the two previous values), or 20%
increase of serum creatinine.

2. Previous episode of ABMR.

3. Previous treatment with plasmapheresis, IVIg, within 2 months prior to inclusion

3b. Previous treatment with rituximab, eculizumab or bortezomib within 1 year prior to
inclusion

4. Major lesions of active antibody-mediated injury, as defined by Banff criteria, such as
g + ptc >3 or chronic transplant glomerulopathy (cg>0).

5. History of cardiac insufficiency (New York Heart Association [NYHA] III/IV),
cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced
ischemic heart disease, congestive heart failure or severe hypertension.

6. History of thrombotic episodes (deep vein thrombosis, myocardial infarction,
cerebrovascular accident).

7. Known allergic or other severe reactions to blood products including intolerability to
previous IVIg (i.e. severe headache, hypersensitivity, intravascular hemolysis).

8. Subject with a known deficit in IgA, with antibodies against IgA. 9. Known
hyperprolinemia.

10. Ongoing HIV, hepatitis C and hepatitis B infection.

11. Any condition (including alcohol, drug or medication abuse) that is likely to interfere
with evaluation of the study product or satisfactory conduct of the study.

12. Not able to comply with study procedures and treatment regimen.

13. Pregnant or lactating women or women of childbearing potential without effective method
of contraception (oral contraceptive pill, intra-uterine contraceptive device,
contraceptive implant or condom).

14. Participation in any other study involving investigational products, concomitantly or
within 30 days prior to entry in the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Kidney Transplantation

Intervention(s)

Drug: Privigen (Human normal immunoglobulin G (IgG > 98 % purity))

Primary Outcome(s)

Graft function: estimation of change from baseline Glomerular Filtration Rate (GFR) using MDRD [Time Frame: at months 12]

Graft function: estimation of change from baseline Glomerular Filtration Rate (GFR) using MDRD [Time Frame: at months 6]

Secondary Outcome(s)

Change of Histological characteristics from baseline [Time Frame: at months 6]

IgG dosage [Time Frame: up to months 6]

Change of HLA-DSA from baseline [Time Frame: months 6 and months 12]

Infectious events reported during the study period [Time Frame: up to months 12]

Change of proteinuria from baseline [Time Frame: months 6 and months 12]

Secondary ID(s)

P140501

2014-003707-30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

CSL Behring

Association ASLUMARE