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Register:	ClinicalTrials.gov
Last refreshed on:	25 January 2021
Main ID:	NCT02523768
Date of registration:	04/08/2015
Prospective Registration:	No
Primary sponsor:	Centre Hospitalier Universitaire de Saint Etienne
Public title:	Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive Treatment PIRAT
Scientific title:	Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive Treatment
Date of first enrolment:	January 8, 2011
Target sample size:	117
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT02523768
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment
France

Contacts

Name:	Francois BERTHOUX, MD PhD
Address:
Telephone:
Email:
Affiliation:	CHU de SAINT-ETIENNE

Key inclusion & exclusion criteria

Inclusion Criteria:

- Free, informed, express and written.

- Diagnosis of native kidney primary IgA glomerulonephritis biopsy-proven

- First kidney transplantation (one kidney)

Exclusion Criteria:

- Panel Reactive Antibody (PRA PRA global or class I or class II PRA) over 50% on a
serum before transplantation

- Multi-organ graft

- Transplants using donor limits or sub-optimal: donor age = 70 years, donors in the
study BIGRAS or taken heart beating donors (tested on computer infusion) or other
restriction factors

- IgA glomerulonephritis secondary to HSP (Henoch-Schonlein purpura) or Systemic Lupus
Erythematosus (SLE) or alcoholic cirrhosis

- History of cancer older than 5 years or with advanced cancer, but except for
non-recurrent skin cancers

- Infectious diseases scalable: tuberculosis, HIV, Hepatitis B virus or Hepatitis C
virus infection with viral replication and / or chronic hepatitis

- Allergy to rabbit proteins

- Severe thrombocytopenia (<50,000 platelets/ul)

- Bacterial infection, viral and fungal uncontrolled therapeutically

- Pregnancy or lactation

Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Glomerulonephritis

IgAN

Intervention(s)

Drug: Simulect

Drug: ATG-F

Primary Outcome(s)

histological recurrence [Time Frame: 5 years]

clinical recurrence [Time Frame: 5 years]

Secondary Outcome(s)

Secondary ID(s)

2009-018189-36

A100405-32

0908143

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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