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Nephritis clinical trials

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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).

NCT ID: NCT05268289 Recruiting - Lupus Nephritis Clinical Trials

Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V

Start date: August 10, 2022
Phase: Phase 2
Study type: Interventional

The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

NCT ID: NCT05207358 Recruiting - Lupus Nephritis Clinical Trials

Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis

GLUREDLUP
Start date: March 2, 2022
Phase: Phase 4
Study type: Interventional

The aim of the study is to evaluate the efficacy of a therapeutic regimen which decreases glucocorticoid exposure compared with standard therapy in patients with proliferative lupus nephritis during remission induction by evaluating the histological and clinical remission.

NCT ID: NCT05201469 Recruiting - Lupus Nephritis Clinical Trials

VIBRANT: VIB4920 for Active Lupus Nephritis

VIBRANT
Start date: May 16, 2022
Phase: Phase 2
Study type: Interventional

This is a multi-center double-blind placebo controlled clinical trial evaluating the efficacy of VIB4920 combined with mycophenolate mofetil (MMF) and prednisone in achieving a renal response in participants with active lupus nephritis (LN).

NCT ID: NCT05138133 Recruiting - Lupus Nephritis Clinical Trials

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

IRIS
Start date: February 15, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

NCT ID: NCT05126277 Recruiting - Lupus Nephritis Clinical Trials

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

SIRIUS-LN
Start date: July 14, 2022
Phase: Phase 3
Study type: Interventional

This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN

NCT ID: NCT05097989 Recruiting - Lupus Nephritis Clinical Trials

Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

Start date: January 14, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of ALXN2050 (120 and 180 milligrams [mg]) in addition to background therapy consistent with the standard of care in adult participants (≥ 18 to ≤ 75 years of age) with either LN or IgAN. The study will consist of an up to 6-week Screening Period, a 26-week blinded Initial Evaluation Period, a 24-week blinded Extended Treatment Period, and an Open-label Extension (OLE) Period of up to 2 years. Safety will be monitored throughout the study.