Abstract: TH-PO1208
Intensive Supportive Care Plus Immunosuppression in IgA Nephropathy: Long-Term Renal Outcomes
Session Information
- Late-Breaking Clinical Trials Posters
November 07, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- No subcategory defined
Authors
- Floege, Jürgen, RWTH Aachen University, Aachen, Germany
- Wied, Stephanie, RWTH Aachen University, Aachen, Germany
- Fitzner, Christina, RWTH Aachen University Hospital, Aachen, Germany
- Eitner, Frank, RWTH Aachen University, Aachen, Germany
- Sommerer, Claudia, University Hospital of Heidelberg, Heidelberg, Germany
- Zeier, Martin G., University Hospital of Heidelberg, Heidelberg, Germany
- Otte, Britta, Universitätsklinikum Münster, Muenster, Germany
- Panzer, Ulf, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
- Budde, Klemens, Charite Universitatsmedizin Berlin, Berlin, Germany
- Benck, Urs, University Medicine Mannheim, Mannheim, Germany
- Mertens, Peter R., Otto-von-Guerricke University, Magdeburg, Germany
- Kuhlmann, Uwe, Klinikum Bremen Mitte, Bremen, Germany
- Witzke, Oliver, University Duisburg-Essen, Essen, Germany
- Gross, Oliver, University Medicine Goettingen, Goettingen, Germany
- Vielhauer, Volker, Ludwig-Maximilians-University Munich, Munich, Germany
- Mann, Johannes F., KfH Nierenzentrum, München, Germany
- Hilgers, Ralf-dieter, RWTH Aachen University, Aachen, Germany
- Rauen, Thomas, RWTH Aachen University Hospital, Aachen, Germany
Group or Team Name
- for the STOP-IgAN investigators
Background
Our randomized, controlled STOP-IgAN trial in patients with IgA nephropathy (IgAN) and substantial proteinuria failed to detect a benefit of immunosuppression added on top of supportive care on the decline in estimated glomerular filtration rate (eGFR) over 3 years. We now evaluated long-term renal outcomes after observational follow-up.
Methods
We obtained information on serum creatinine, proteinuria, end-stage renal disease (ESRD) and death as censored by 03/31/2018. The primary endpoint was the time to first occurrence of a composite of all-cause death, ESRD or eGFR decline by ≥40% as compared to baseline, i.e. randomization in the STOP-IgAN trial (Cox-regression).
Results
Long-term data were available for 149 STOP-IgAN participants (i.e. 92% of the patients originally randomized). Median follow-up after randomization was 7.4 years (IQR 5.7-8.3 years). The primary endpoint was reached in 36 patients (50.0%) originally randomized to supportive care and 35 patients (45.5%) of those receiving additional immunosuppression (HR 1.20; 95%-CI 0.75 to 1.92; p=0.45). ESRD occurred in 17 patients (23.6%) in the supportive care arm and in 20 patients with additional immunosuppression (26.0%). An eGFR loss ≥40% occurred at the same rate in both arms and annual eGFR loss also did not differ significantly. Two patients in the supportive-care arm and three in the arm with additional immunosuppression died during follow-up.
Conclusion
Over a follow-up of up to 10 years, we failed to detect differences in key clinical outcomes in IgAN patients randomized to receive added immunosuppression on top of supportive care versus supportive care alone (ClinicalTrials.gov number, NCT03488368).
Primary endpoint analysis. Kaplan-Meier curves showing survival without occurrence of the primary endpoint in the STOP-IgAN cohort.