In breve
Clinical trials are investigating "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)" in adults with antibody-mediated rejection after kidney transplantation. The study looks at whether this treatment is safe and effective compared with placebo, especially for histologic healing seen on kidney biopsy.
Punti chiave
- One clinical trial is listed for 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). It is a Phase 2, interventional study in adults with antibody-mediated rejection after kidney transplantation. The study is authorised and includes about 50 participants. The main question is whether the treatment improves biopsy-proven histologic resolution by Week 52 compared with placebo. This means researchers are checking if the kidney tissue looks better on biopsy after treatment.
Clinical trial overview
One authorised study is investigating 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 in adults with antibody-mediated rejection after kidney transplantation.
Who the trial is for
The study is for adults with antibody-mediated rejection after kidney transplantation. The summary also says the participants may have active or chronic active antibody-mediated rejection, which means the rejection can be happening now or continuing over time.
Study design and phase
This is a Phase 2 interventional study. In a Phase 2 trial, researchers look at early signs of benefit and safety in a smaller group of people.
The trial compares the study treatment with vialed saline placebo, which is an inactive treatment used for comparison. The listed enrollment is 50 participants.
Main endpoint
The main endpoint is biopsy-proven histologic resolution at Week 52. A biopsy is a small sample of tissue, and histologic resolution means the tissue looks healed or improved under the microscope.
This endpoint matters because it shows whether the kidney transplant rejection has improved in a way that can be seen directly in the kidney tissue.
What the results are meant to show
The brief summary says the study is designed to compare ALXN2030 with placebo for biopsy-proven histologic resolution in participants with active or chronic active antibody-mediated rejection at Week 52.
For patients, this means the trial is not only checking whether the treatment is tolerated, but also whether it may help the transplanted kidney recover better on biopsy after about one year.