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Nephritis clinical trials

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NCT ID: NCT05540665 Terminated - Lupus Nephritis Clinical Trials

Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN)

Start date: April 26, 2023
Phase: Phase 2
Study type: Interventional

Phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of daxdilimab in patients with active, proliferative lupus nephritis (LN).

NCT ID: NCT05538208 Recruiting - Lupus Nephritis Clinical Trials

The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study

PLUMM
Start date: January 2024
Phase: Phase 2
Study type: Interventional

The study is a 1-year 2-part double-blinded placebo controlled 2-arm clinical trial. Treatment arms are (1) MMF dosed as per body-surface area (MMFBSA; 600mg/m2 body surface area per dose about every 12 hours) and (2) pharmacokinetically-guided precision-dosing of MMF (MMFPK; MMF dosed twice daily to achieve an area under the concentration-time curve (AUC0-12h) of MPA >60-70 mg*h/L. The study goal is to determine the safety and efficacy of MMFPK compared to MMFBSA for the treatment of proliferative LN in subjects 8 to <18 years.

NCT ID: NCT05508009 Recruiting - Cystinosis Clinical Trials

Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant From the Same Donor

Start date: January 10, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single center, non-randomized, non-controlled open-label phase 1b/2a trial of performing sequential αβdepleted-HSCT and KT in patients requiring KT to prevent kidney rejection post-KT, in the absence of any post-KT immunosuppression, to abrogate the need for lifelong immunosuppression, the risk of chronic rejection and, ultimately, the need for repeated transplantation.

NCT ID: NCT05495893 Recruiting - Lupus Nephritis Clinical Trials

MMF Versus CYC in the Induction Therapy of Pediatric Active Proliferative LN

MyCITS
Start date: July 25, 2022
Phase: Phase 4
Study type: Interventional

A prospective, randomized, multicenter, open-label, parallel-arm Study to compare effectiveness of mycophenolate mofetil versus cyclophosphamide in the Induction Therapy of pediatric patients with Active Proliferative Lupus Nephritis in Chinese population

NCT ID: NCT05443516 Recruiting - Lupus Nephritis Clinical Trials

Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus

JD001
Start date: June 16, 2014
Phase:
Study type: Observational

The aim of this research project is to better understand the origin and clinical significance of two lupus-specific "genetic signatures" (IFN signature and plasma cell signature) in patient subgroups with well-defined clinical characteristics. Our aim is to correlate these genetic signatures with cell activation profiles and the production of specific cytokines in different populations from whole blood and in short-term cultures of these circulating cells.

NCT ID: NCT05432531 Active, not recruiting - Lupus Nephritis Clinical Trials

Efficiency of Use of Baracetinib in Treatment of Lupus Nephritis

Start date: June 1, 2022
Phase: Phase 3
Study type: Interventional

Patients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus and had a diagnosis of systemic lupus erythematosus, and had active renal disease as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug.

NCT ID: NCT05402735 Recruiting - Uric Acid Clinical Trials

Value of Uric Acid as Early Predictor of Lupus Nephritis

Start date: June 15, 2022
Phase:
Study type: Observational

The aim of the present work is to determine the role of uric acid as a predictor and prognostic factor in the development of lupus nephritis.

NCT ID: NCT05358652 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Precision Medicine in LN: A Multicenter Proof-of-concept Study for Histopathological Biomarkers Analysis in Renal Biopsy

Start date: October 15, 2021
Phase:
Study type: Observational

Lupus nephritis (LN) may affect approximately half of patients with Systemic Lupus Erythematosus (SLE). LN is a major cause of morbidity and the most important predictor of mortality in patients with SLE. Some 5-20% of patients with LN may develop end-stage renal disease within 10 years of follow-up from the time of diagnosis. Other studies have described progression to end-stage renal disease in 10-30% of patients with LN. The European League Against Rheumatism, the European Renal Association and the European Dialysis and Transplant Association have recently updated their recommendations for the management of LN. These recommend the use of intravenous (IV) methylprednisolone boluses followed by lower doses of oral glucocorticoids (GC) and place mycophenolate mofetil (MMF) and the European regimen of cyclophosphamide (CYC) as the immunosuppressive drugs of first choice, with the IV CYC regimen for certain more aggressive cases. They also consider the use of "multitarget therapy" based on the combination of tacrolimus (TAC) and MMF and GC in patients with proteinuria in the nephrotic range who have not responded to the first line of treatment. For refractory active renal disease, they recommend as an alternative the use of rituximab (RTX) 1000 mg IV repeated after 15 days. Belimumab has been shown to be significantly more effective than placebo in the treatment of patients with active LN. This finding will lead to positioning belimumab in the therapeutic algorithm for LN. However, in clinical practice these immunosuppressive drugs are not always effective in the treatment of LN, and even one in 3 patients with an initial favorable response may experience renal recurrence. The choice of the appropriate treatment for LN and its early initiation are key to improve the prognosis of these patients and to avoid progression to chronic renal failure. The identification of biomarkers capable of predicting the response (or lack thereof) to one or another therapy at the time of LN diagnosis would allow to implement precision medicine, thus constituting a revolution in the treatment of patients with LN. Allows more targeted treatments with greater specificity to be established. The objective of this project is to analyze histopathological biomarkers in the renal biopsy to predict the renal response to the different drugs used in the treatment of LN. This would contribute to a more specific and cost-effective therapeutic strategy.

NCT ID: NCT05337124 Recruiting - Lupus Nephritis Clinical Trials

A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US

ENLIGHT-LN
Start date: March 25, 2022
Phase:
Study type: Observational [Patient Registry]

This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in adult patients with lupus nephritis (LN) in the United States (US).

NCT ID: NCT05288855 Recruiting - Clinical trials for Adolescent Lupus Nephritis

Voclosporin in Adolescents With Lupus Nephritis

VOCAL
Start date: October 10, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescents with active lupus nephritis (LN).