- Arbeitsgruppe Nephropathologie der MHH (NP-MHH)
- Auswahl eigener Projekte der NP-MHH:
- Mitarbeit an Studien / consent reading
Mitarbeit an Studien - NP-MHH / consent reading
1. Standardized diagnostik workup and histopathological report on all renal transplant biopsies being taken within the IFB-Tx program following a uniquely developed protocol including a complete actual Banff classification (executive nephropathologist since 04/2014)
2. Clinical Protocol IM103116: Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (belatacept)-based Immunosuppression. Study Phase: 3b – (three renal transplant centres)
3. Clinical Protocol: HGS1006-C1121 (Human Genome Sciences): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab plus Standard of Care versus Placebo plus Standard of Care in Adult Subjects with Active Lupus Nephritis. Phase: 3
4. Clinical Protocol: QRK306: A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant. Phase 3
5. Clinical Protocol: 200710602 „RIACT”: Double blind controlled trial on Rituximab/MabThera® in comparison to steroid alone in acute cellular rejection in renal transplants.
6. Clinical Protocol: Mass spectrometry (DFG): Non-invasive diagnosis of acute rejection in renal transplant patients using mass spectrometry of urine samples. A multicentre diagnostic phase 3 trial
7. Clinical Protocol: 3xBIOS² study: Biomarkers of renal graft injuries in kidney allograft recipients (BIOMARGIN)
8. Controlled trial (CL011_168): Evaluation of Avacopan in C3 glomerulopathy.
9. Clinical Protocol: D3461C00007: Multicentre, randomised, double-blind, placebo-controlled, Phase 2 Study Evaluation of the efficacy and safety of Anifrolumab in adult subjects with active proliferative Lupus nephritis
10. “Kidney Doc”: Prospective multicentre study aiming at standardizing and harmonizing the nationwide anti-rejection strategy/therapy in renal transplant patients being biopsied. Study started with 2 centres: University of Schleswig-Holstein, Campus Kiel, Clinic for Nephrology and Hypertension and Department of Nephrology, Clinics Rechts der Isar, Technical University of Munich.
11. CRAD001A2429: A 24 months, multi-center, open-label, randomized, controlled trial to investigate efficacy, safety and evolution of cardiovascular parameters in de novo renal transplant recipients after early calcineurin inhibitor to everolimus conversion. 2011-2015 (UK Essen)
12. CCFZ533X2201: A 12-months randomized, multiple dose, open-label, study evaluating safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of an anti-CD40 monoclonal antibody, CFZ533, in combination with mycophenolate mofetil (MMF) and corticosteroids (CS), with and witout tacrolimus (Tac), in de novo renal transplant recipients. 2016-2017