Auxora for the Treatment of AKI and Modulation of Injurious “Crosstalk” with the Lung: A Randomized Control Trial (KOURAGE)

Internal Medicine Nephrology Pulmonology Endocrinology Kidney Disease Respiratory Distress Syndrome Respiratory Failure Kidney Failure Diabetes Adult Subjects

Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be randomly assigned to either Auxora or matching placebo. Study drug infusions will occur every 24 hours for five consecutive days for a total of five infusions.

VX21-147-301, VX-147, for APOL1

Internal Medicine Nephrology Kidney Disease Pediatric Subjects Adult Subjects

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.

Apellis Extension 314

Pediatrics Nephrology Kidney Disease Pediatric Subjects Adult Subjects

This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).

417-201-00007, Sibeprenlimab, IgAN

Internal Medicine Nephrology Kidney Disease Adult Subjects

This is a phase 3 study to evaluate effects on proteinuria and glomerular filtration rate of sibeprenlimab 400 mg subcutaneously (s.c.) Q 4 weeks in adults with IgAN who are receiving maximally tolerated standard-of-care therapy.

CLNP023B12301

Pediatrics Nephrology Kidney Disease Pediatric Subjects Adult Subjects

The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol.

The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.

The Effects of the CF Carrier State on the Kidneys and Pancreas

Internal Medicine Gastroenterology Pulmonology Endocrinology Nephrology Pancreas Lung Disease Diabetes Kidney Disease Adult Subjects Female Subjects Male Subjects

The overarching hypothesis is that CF carriers are at increased risk for developing most of the extrapulmonary conditions associated with CF compared to the general population. Specifically, it is hypothesized that this pilot data will detect subclinical evidence of pancreatic and kidney disorders among CF carriers. This will be determined by bringing CF carriers and controls to the CRU for one visit where they will answer survey questions and undergo laboratory testing. Additionally, they will collect urine and stool samples at home that will be sent to outside laboratories for testing.

AREN1921: Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Cancer Pediatrics Nephrology Endocrinology Kidney Disease Thyroid Disorders Sarcoma Pediatric Subjects Adult Subjects

This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).