Clinical Research Directory

A Study to Evaluate the Safety, Tolerability and PK of SK-09

This Phase 1 trial consists of two parts: Part 1 is a Single Ascending Dose (SAD) study, and Part 2 is a Multiple Ascending Dose (MAD) study. Both parts adopt a randomized, double-blind, placebo-controlled design.

NEPTUNE Match Study

NEPTUNE Match is an additional opportunity offered to NEPTUNE study participants to prospectively recruit and communicate patient-specific clinical trial matching with kidney patients and their physician investigators.

A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB

DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor that, when administered concurrently with an ARB, is designed to inhibit recruitment of monocytes implicated in the inflammatory chemokine environment of chronic disease. The purpose of this pivotal randomized double-blind study is to investigate the efficacy and safety of DMX-200 120 mg twice daily (BID) compared with placebo over a treatment period of 104 weeks in adult patients with FSGS who are being treated with an ARB. Given the rarity of the disease and the similarities between adults and pediatric patients with FSGS, Dimerix will also investigate the efficacy and safety of DMX 200 in adolescents aged 12 to 17 years. The double-blind period will be followed by an open-label extension (OLE) which aims to assess the long-term efficacy and safety of DMX 200 for up to 2 additional years.

Atacicept in Multiple Glomerular Diseases

The purpose of this study is to evaluate the safety and tolerability of atacicept in adult and adolescent participants and to measure the effect in reducing proteinuria and preserving renal function.

Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.

Researchers from the University of Michigan and Northwestern University are studying people's experiences with swelling caused by Nephrotic Syndrome. Interviews with patients (child and adult) and parents of young children will be conducted. The information collected from the interviews will be used to develop a survey to use when testing new medications for Nephrotic Syndrome. Please consider participating in a 1-hour long interview with the Prepare-NS research study to discuss children and adults experiences with swelling.

A Sequential Phase 2/3 Study of APL2 in Patients With Focal Segmental Glomerulosclerosis

This is a sequential phase 2/3 study to evaluate the efficacy and safety of twice-weekly subcutaneous (SC) infusions of APL2 in patients diagnosed with FSGS. The initial phase 2 portion is a single-arm, open-label study in adults diagnosed with FSGS. Phase 2 will commence prior to randomizing for phase 3. The phase 3 portion of the study is a randomized, placebo-controlled, double-blinded, multicenter study in adults and adolescents diagnosed with FSGS.

Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis and Minimal Change Disease

The morbidity of recurrence of focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) after transplant is well-recognized and include contemporary reduction in quality of life, edema, early graft loss and mortality. Efforts to understand its mechanisms and improve its treatment have been limited by small sample sizes in single center studies and misclassification in registry studies. Recent advances in the understanding of the mechanisms of FSGS in the native kidney has reinvigorated the scientific community to develop a collaborative community to advance research into the epidemiology, mechanisms, interventions, and outcomes. The purpose of RESOLVE is to gather a group of people with FSGS and MCD that have had or will have a kidney transplant to create a bank of information and biospecimens so researchers can more effectively study these diseases.

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

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.