Table of Contents

• Clinical trial overview
• Study design and phase
• Who can participate
• Main outcome measure
• Trial summary

Clinical trial overview

This clinical trial is studying whether RNA, (AM-SP-UM-CM-AM-AM-CM-UM-(2′-DEOXY-2′-FLUORO)C-(2′-DEOXY-2′-FLUORO)A-(2′-DEOXY-2′-FLUORO)C-(2′-DEOXY-2′-FLUORO)C-UM-GM-UM-AM-AM-UM-AM-AM-AM-GM-CM-AM-GM-CM-CM-GM-[2′-O-[[2-[2-[[5-[[2-(ACETYLAMINO)-2-DEOXY-BETA-D-GALACTOPYRANOSYL]OXY]-1-OXOPENTYL]AMINO]ETHOXY]ETHOXY]METHYL]]A-[2′-O-[[2-[2-[[5-[[2-(ACETYLAMINO)-2-DEOXY-BETA-D-GALACTOPYRANOSYL]OXY]-1-OXOPENTYL]AMINO]ETHOXY]ETHOXY]METHYL]]A-[2′-O-[[2-[2-[[5-[[2-(ACETYLAMINO)-2-DEOXY-BETA-D-GALACTOPYRANOSYL]OXY]-1-OXOPENTYL]AMINO]ETHOXY]ETHOXY]METHYL]]A-GM-GM-CM-UM-GM-CM), COMPLEX WITH RNA ([4′-DE(HYDROXYMETHYL)-4′-[(HYDROXYMETHOXYPHOSPHINYL)METHOXY]]UM-SP-(2′-DEOXY-2′-FLUORO)U-SP-(2′-DEOXY-2′-FLUORO)U-(2′-DEOXY-2′-FLUORO)A-(2′-DEOXY-2′-FLUORO)U-UM-(2′-DEOXY-2′-FLUORO)A-CM-AM-(2′-DEOXY-2′-FLUORO)G-GM-UM-GM-(2′-DEOXY-2′-FLUORO)A-GM-UM-UM-GM-AM-UM-SP-GM-SP-GM) is effective and safe for adults with antibody-mediated rejection after kidney transplantation.^[1]

The study compares the trial treatment with placebo, which is a look-alike treatment without the active study medicine.^[1]

Study design and phase

This is an interventional study, which means researchers assign a treatment and then measure the results.^[1]

The trial is in Phase 2, a stage that usually looks more closely at whether a treatment may work while still checking safety.^[1]

The status is Authorised, and the planned enrollment is 50 participants.^[1]

Who can participate

The target population is adults who have antibody-mediated rejection after a kidney transplant.^[1]

The brief summary says the study includes people with active or chronic active antibody-mediated rejection, so the trial is focused on patients whose rejection is currently happening or still ongoing over time.^[1]

Main outcome measure

The main outcome is biopsy-proven histologic resolution at Week 52.^[1]

In simple words, the researchers take a tissue sample from the kidney transplant and look at it under a microscope to see whether the signs of rejection have improved by about one year after the start of the study.^[1]

Trial summary

Only one trial was provided in the source data, so the summary is short.^[1]