Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease

Launched by CENTRE HOSPITALIER DEPARTEMENTAL VENDEE · Oct 26, 2017

Keywords

ClinConnect Summary

This clinical trial is looking at whether patients with a specific type of kidney disease, known as ANCA-associated vasculitis (AAV), who are also in end-stage renal disease (ESRD), can stop taking their immunosuppressive medications safely. These medications help prevent the body from attacking itself, but they can also lead to complications like infections. The researchers want to find out if stopping these treatments will lead to fewer health issues over two years compared to continuing them while keeping an eye on any relapses of the disease.

To be part of this study, participants need to be between 18 and 90 years old and have been diagnosed with AAV that has affected their kidneys. They should also be experiencing end-stage renal disease, meaning their kidneys are functioning very poorly. The trial is currently recruiting participants, and those who join will be randomly assigned to either stop their immunosuppressive therapy or continue it. Throughout the study, patients will be monitored for any serious health events, infections, or relapses of their condition. This research aims to improve understanding of how to manage the health of patients dealing with these challenging conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years and ≤ 90 years
• • Patients affected by a GPA or MPA AAV with a renal injury
• • Patients with initial manifestation or relapse of AAV
• • Patients with ESRD, defined by a glomerular filtration rate estimated using the MDRD formula ≤15 mL/min or requirement for dialysis for more than 60 days
• • Patients with ESRD on native kidney
• • Patients who gave written informed consent for participation in the study
• • Patients with affiliation to the French social security system
• Exclusion Criteria:
• • Patients who experienced severe extra-renal disease due to AAV (intra-alveolar haemorrhage with blood oxygen saturation ≤ 85% on room air or ventilated, or central nervous system disease) in the last 12 months prior to inclusion
• • Patients with AAV-associated renal involvement (with active inflammatory lesions in kidney biopsy) diagnosed less than three months and receiving induction treatment with cyclophosphamide or rituximab or diagnosed less than 45 days for patients who have receveid only treatment based on steroid infusion without cyclophosphamide or rituximab
• • Patients who received maintenance immunosuppressive treatment for more than 6 months during the last 12 months
• • Patient with a diagnosis of vasculitis other than GPA or MPA
• • Patients with another immunologic systemic disease (Lupus, sarcoidosis...) Patients with active HCV, HBV or HIV infection
• • Patients with a history of serious viral infection (CMV, HHV8, etc.) in the 2 months prior to the inclusion, or severe uncontrolled chronic infection (tuberculosis, etc.)
• • Patients with uncontrolled cancer or hemopathy
• • Kidney transplant patient
• • Inability to understand and sign the informed consent
• • Pregnant women.
• • Women of child-bearing age without effective method of contraception
• • Age \< 18 years or \> 90 years.
• • Patients under guardianship or trusteeship.