Nephritis

This research aims to evaluate antibiotic treatments for acute pyelonephritis (AP) in children aged 1 month to 3 years. It compares a shorter intravenous (IV) antibiotic course of 3 days alone to a longer treatment consisting of 3 days IV followed by 7 days of oral antibiotics. The goal is to see if the shorter IV treatment is as effective in curing AP and preventing recurrence and renal scarring, while reducing the risk of antibiotic resistance and preserving gut microbiota diversity. Participants are randomly assigned to one of two groups. The experimental group receives only 3 days of IV antibiotics with ceftriaxone and/or amikacin, after which treatment is stopped. The control group receives the usual care of 3 days IV antibiotics followed by 7 days of oral antibiotics, either cotrimoxazole or cefixime. The study includes collection of fecal or rectal swabs and blood tests to assess microbiota and resistance. Treatment effectiveness and safety are compared between groups. During the study, children are monitored for fever, symptoms, and urine cultures to confirm infection clearance. Researchers measure recurrence of febrile urinary tract infections within 28 days after treatment ends and follow clinical cure at 10 or 17 days depending on the group. Additional assessments include monitoring recurrence at 90 days, antimicrobial resistance in gut bacteria, and intestinal microbiota diversity over about a month. Participation lasts through treatment and follow-up visits up to several weeks.

Researchers are investigating why some men with Benign Prostatic Hyperplasia (BPH), a common condition causing urinary problems due to prostate enlargement, do not respond to the typical treatment drug Finasteride. The study focuses on understanding resistance to this treatment and hopes to use noninvasive methods like MRI to detect prostate inflammation and predict which patients will not benefit from Finasteride, allowing for alternative treatments in the future. Men eligible for the study will receive Finasteride as standard care for BPH symptoms, particularly those with moderate urinary symptoms and a prostate size over 40cc. Participants will undergo prostate MRIs and biopsies, along with blood and urine tests, before starting treatment. They will be monitored every six months with symptom assessments and have follow-up MRIs at three years to track changes in prostate size and inflammation, while tissue samples will be analyzed for gene expression and hormonal levels. Throughout the study, participants will attend clinic visits to evaluate urinary symptoms and treatment response, with a key assessment at 12 months to measure the effect of Finasteride. Researchers will collect detailed data including MRI scans, prostate tissue analyses, and hormone tests to understand treatment resistance. The study aims to improve how BPH is managed by identifying patients unlikely to respond to current therapy, with monitoring continuing over several years to gather comprehensive information.

Researchers are evaluating the safety, tolerability, and how the body processes a new medicine called CPV-104. This medicine is designed to regulate the complement system, which can be overactive in a rare kidney condition called C3 glomerulopathy (C3G). The study includes both healthy adults and adults with C3G to understand how CPV-104 affects different groups and to check for any immune reactions or side effects. The trial has two parts. In the first part, healthy volunteers receive a single intravenous dose of CPV-104 or a placebo in a randomized, double-blind setting. In the second part, patients with C3G receive four weekly intravenous doses of CPV-104 without placebo. Dose escalation is allowed if the treatments are well tolerated. All doses are given by healthcare professionals, and a Safety Review Committee monitors safety data to decide on progressing with doses and groups. Participants will be closely monitored throughout the study with checks for side effects, blood and urine tests, ECGs, vital signs, and blood samples to measure drug levels and antibodies. For patients with C3G, kidney function is also observed. The main focus is on safety rather than effectiveness. The study tracks serious and severe drug reactions up to Day 29 for healthy volunteers and Day 50 for C3G patients. Participation includes a screening period and follow-up assessments to ensure safety and gather important information about CPV-104.

Researchers are evaluating whether using an automated Carbon Dioxide (CO2) injection system during infrainguinal peripheral vascular interventions (PVI) can reduce major adverse kidney events within 90 days in patients at moderately increased risk for contrast-associated acute kidney injury (CA-AKI). This Phase 3 randomized controlled trial compares a CO2-based contrast medium sparing strategy to the standard use of iodinated contrast media in patients with peripheral vascular and kidney diseases. Participants are randomly assigned to one of two groups. The intervention group receives PVI using an automated CO2 injection system as the primary contrast agent, with iodinated contrast media available as a backup if image quality is insufficient or if the patient cannot tolerate CO2 angiography. The control group undergoes routine PVI using iodinated contrast media according to local standards, avoiding high-osmolar contrast agents. All patients are followed for up to 12 months after their procedure. During the study, participants undergo the planned PVI procedure with either contrast method. Researchers carefully record the amount and reasons for any iodinated contrast media used in the CO2 group. Patients are monitored for kidney-related outcomes, focusing on major adverse kidney events up to 90 days after the intervention. The trial includes ongoing follow-up assessments to evaluate safety and effectiveness over one year.

Researchers are studying the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-10390 in healthy adults aged 18 to 45 years. This Phase 1 trial aims to understand how the drug behaves in the body and how well it is tolerated when taken in different doses. The study specifically involves healthy volunteers to gather initial data before testing in patients with conditions like IgA Nephropathy or Focal Segmental Glomerulosclerosis. The study uses a randomized, double-blind, placebo-controlled design with single and multiple ascending dose (SAD and MAD) periods. There will be about six sequential groups for single doses and three for multiple doses. Participants will receive oral tablets of HS-10390 or a matching placebo while fasting. The multiple dose phase begins after safety and PK data from the single dose phase are reviewed. A sentinel dosing approach is used in the first single dose group to enhance safety. Participants will be monitored from Day 1 up to Day 12 for single doses and up to Day 28 for multiple doses. Researchers will assess adverse events, serious adverse events, and any events leading to stopping the study drug. They will also measure drug levels in the blood over time to understand how quickly and extensively the drug is absorbed, distributed, and cleared. Safety checks include physical exams, lab tests, vital signs, ECGs, and imaging as needed. The total study duration varies by participant depending on the dosing schedule and monitoring requirements.

This research focuses on people who have previously been treated with KYV-101, an autologous CAR T cell therapy, to monitor long-term safety and persistence of the treatment. It aims to collect information about delayed side effects and ongoing presence of the gene-modified cells in participants who received at least one infusion of KYV-101 in earlier clinical trials sponsored by Kyverna Therapeutics. Participants in this observational study will continue to be followed for up to 15 years after their initial KYV-101 treatment. The study will track various health outcomes including treatment-related adverse events, new or returning malignancies, neurological and autoimmune conditions, blood disorders, infections, and specific laboratory tests related to the therapy. For some participants with certain conditions, additional measures like medication use and functional assessments will be monitored for shorter periods. Throughout the study, participants will undergo regular health evaluations, lab tests, and questionnaires to assess the long-term effects of KYV-101. Researchers will collect data on safety events and laboratory markers up to 15 years, with some specific tests monitored up to 5 years. The overall goal is to better understand the long-term impact and safety profile of the gene-modified therapy in people treated previously.

Researchers are conducting a prospective, observational study to understand the full range of symptoms, treatment use, and overall quality of life experienced by patients with Immunoglobulin A nephropathy (IgAN) and their caregivers. The study aims to capture detailed data on these aspects over time to better reflect the patient experience and treatment patterns in the US. Participants will use the Folia Health mobile platform to enroll and provide data. The study includes IgAN patients taking different treatments such as iptacopan, atrasentan, other specific treatments, or no treatment, along with their caregivers. Each participant will complete a 6-month data collection period involving home-reported outcomes, baseline surveys, monthly check-ins, and an endline survey. After this period, participants may continue tracking symptoms for personal use, with optional data sharing for up to 2 years. During the study, participants report symptoms and treatment details monthly to assess symptom presence, severity, and variability. Researchers will also monitor treatment frequency, reasons for skipping treatment, and quality of life changes. Data collection includes patient-reported outcome scores and flare burden classification. The study involves no interventions and focuses on observation via the mobile app over the initial 6 months and potentially longer for ongoing data integration.

Researchers are evaluating the safety and effectiveness of starting budesonide enteric coated capsules early to treat primary IgA nephropathy, a kidney condition. This prospective, open-label study involves multiple centers and aims to observe changes in proteinuria levels and monitor for any treatment-related abnormal lab values or adverse events over about 12 months. Participants will receive targeted-release budesonide capsules as part of the study. The research includes collecting and testing Gd-IgA1 levels in enrolled subjects. The study is observational, focusing on early initiation of therapy for patients diagnosed within 3 months, with kidney function and protein levels meeting specific criteria. During the study, participants will be regularly assessed for kidney function, protein in urine, microscopic hematuria, and metabolic changes through laboratory tests and urine analysis. Researchers will also track serious kidney outcomes and side effects related to treatment. The total participation period covers about 12 months, including follow-up to evaluate the long-term effects of the therapy.

This research focuses on kidney transplant patients to collect blood samples and clinical data for developing a non-invasive test that detects donor-derived cell-free DNA (dd-cfDNA) to assess the condition of transplanted kidneys. The study is prospective and multicenter, involving participants who have had a kidney transplant and are undergoing an indication biopsy. The goal is to improve monitoring of the transplanted organ's status. Participants will provide whole blood samples at the time of their indication biopsy, before the biopsy procedure itself. Additionally, leftover de-identified retrospective genomic DNA (gDNA) samples from the kidney donors will be collected for paired analysis. This approach helps researchers study dd-cfDNA in a real-world transplant population. Participants will be involved through blood sample collection and clinical data gathering during their biopsy visits. Researchers will monitor the detection of donor-derived cell-free DNA in whole blood over an 18-month period. The study involves no investigational treatments, focusing on observation and sample analysis. Participation duration and follow-up details align with the biopsy schedule and sample collection requirements.

Researchers are evaluating FT819, an investigational drug, in a phase 1 study for people aged 12 to 70 with moderate-to-severe active B-cell mediated autoimmune diseases. These conditions include systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study aims to assess the safety, how the drug is processed in the body, and its effect on B cells. The trial is sponsored by Fate Therapeutics and includes a dose-escalation stage followed by an expansion stage to further evaluate safety and activity. Participants will receive FT819 through intravenous (IV) infusion at planned dose levels. The study includes several treatment regimens, some using FT819 with an auxiliary medicinal product (AMP) and some without, combined with background therapies or temporarily suspending them. Other drugs such as fludarabine, cyclophosphamide, and bendamustine may also be administered as IV infusions at planned dose levels. The trial is non-randomized and open-label, with different dosing schedules including single or two-dose regimens. Participants will be closely monitored for treatment-emergent adverse events and dose-limiting toxicities up to approximately two years. Researchers will measure the plasma concentration of FT819, disease activity, and quality of life at designated time points. Safety assessments and evaluations of disease activity, including lupus nephritis when applicable, will be conducted throughout the study. The total participation time may extend up to two years to gather comprehensive safety and activity data.