Hansa Medical is currently reviewing imlifidase in HLA-sensitized kidney transplant clients. Full information of the professional program are readily available through a main data source. See clinicaltrials.gov for medical research study details on imlifidase.
If you want getting associated with a medical study, please talk to your physician. They will certainly have the ability to recommend you on whether you would be eligible to enroll into a research study and also if participation could be appropriate for you.
Phase I study (Finished).
During 2013 and 2014, Hansa Medical performed a scientific first-in-human Stage 1 research study. The research study was a randomized sugar pill controlled dose-escalation research with 29 (20 energetic plus 9 placebo) healthy and balanced topics.
The objectives were to evaluate safety and security, efficacy in IgG cleavage, pharmacokinetics and also immunogenicity of imlifidase adhering to intravenous management. The starting dosage was 0.01 mg/kg BW as well as the greatest dose group got 0.24 mg/kg BW. Imlifidase was considered secure and also it efficiently deteriorated the plasma IgG. In July 2015, the results from the Phase 1 research study was released in PLOS ONE.
Based upon the data from this study, it was determined to move from healthy subjects into individuals where it is feasible to gauge not only imlifidase impact on plasma IgG however also the result on details pathogenic IgG. The Stage 1 data suggested that imlifidase can show to be a healing alternative in a number of scientific problems.
First clinical Stage 2 in transplantation (Completed).
Throughout 2014 and 2015, the first clinical Phase 2 study with imlifidase treatment in sensitized individuals was carried out as well as finished.The study was a dose-finding research, and the purpose was not to transplant patients through imlifidase therapy.
There were 8 dialysis individuals, varying from extremely highly and also generally vaccinated to more moderately immunized, consisted of in the research study. One group of individuals was provided 0.12 mg/kg BW and one group received 0.25 mg/kg BW imlifidase, as well as the clients were complied with for two months after treatment.
- The result was determined as level of HLA antibodies, cytotoxic cross-match sensitivity against theoretical contributors as well as level of IgG in serum/blood at different time-points after imlifidase therapy.
- Thought about the efficiency of the drug and also the clinical requirement for a treatment of animated clients, we conclude that the risk-benefit favors imlifidase for desensitization prior to transplantation.
The patients participating in this study were not planned for hair transplant under the research procedure. Nonetheless, the clients were not eliminated from the waiting list, as well as the second patient in the study was hair transplanted with an inappropriate kidney following completing imlifidase treatment.
Before imlifidase treatment the cross suit in between contributor and also recipient was positive, yet after treatment it was transformed adverse and also the patient was eligible for transplant. Secure graft function has actually been preserved for greater than one year with typical creatinine as well as no rejection episodes.
Information highly support further growth in animated individuals.
Research to Review the Security, Tolerability, Efficacy and also PK of Imlifidase( IdeS) in Kidney Hair Transplant (Completed).
Stage 2 in Sweden (Finished).
In July 2015, a Stage 2 research in sensitized people was launched in Sweden and in December 2016 the research study was effectively completed. The research has actually included ten animated people on the waiting checklist for hair transplant and the study permitted dose acceleration.
The purposes was to explore both effect on HLA-antibodies and also the safety of imlifidase in the hair transplant setting. The patients have actually gotten a single dose of imlifidase which have enabled kidney transplantation i all patients. Each patient has been followed for 6 months. The primary as well as secondary goals were met with imlifidase (IdeS) in the research.
- Imlifidase in Very Animated Patients Waiting For Kidney Hair Transplant (Finished).
- Detective sponsored Stage 1/2 in Los Angeles (Finished).
In September 2018, a detective funded research study making use of imlifidase (IdeS) was run by Professor Stanley Jordan at Cedars-Sinai Medical Center in Los Angeles was completed.
Professor Jordan has actually formerly created a desensitization procedure that allows transplant of highly sensitized clients making use of kidneys from deceased benefactors, a treatment that is really hard utilizing various other methods based upon plasmapheresis.
The procedure is based on the use of rotating high dose intravenous gamma globulin as well as anti-CD20 therapies in order to reduce the degrees of anti-HLA antibodies and also to prevent rebound of antibodies after inappropriate hair transplant. The individuals are kept in the program for several months waiting on an organ offer from a dead benefactor.
Teacher Jordan has actually investigated imlifidase in combination with the high dose intravenous gamma globulin and anti-CD20 procedure. The research study enrolled 17 individuals and the individuals has been adhered to for six months. The purposes of the research study has actually been to check out both effectiveness (i.e. decrease in PRA, decrease in HLA antibody levels as well as decrease in AMR regularity) and also safety and security of imlifidase.
Results from the research demonstrae that the imlifidase treatment allowed life-saving transplants in all 17 patients. Graft survival at research conclusion, 6 months post-transplantation, was 94%.
Highdes – A Stage 2 Study to Assess the Efficacy of Imlifidase to Desensitize Transplant People With a Favorable Crossmatch Test (Finished).
The Phase 2 research, which was completed in September 2018, registered 18 highly animated clients awaiting kidney hair transplant. Individuals consisted of in this study had either fell short previous attempts of desensitization or the currently readily available methods were thought about insufficiently reliable.
The research study is entitled “A Phase II Research Study to Examine the Efficacy of imlifidase (IdeS (IgG endopeptidase)) to Desensitize Transplant Clients with a Favorable Crossmatch Examination” with the short name Highdes.
The main purpose of the research has actually been to examine the effectiveness of imlifidase in developing a negative crossmatch test in very sensitized people with a favorable crossmatch examination to their offered benefactor. Transforming the crossmatch examination makes it possible for hair transplant in clients who would certainly otherwise not get approved for hair transplant.
The study has additionally evaluated safety, kidney function and also immunogenicity during a 6-month follow-up period. The Highdes-study was started in October 2016 and finished in September 2018.
5 sites have actually hired individuals to the Highdes research:.
- Cedars-Sinai Medical Center in Los Angeles, USA.
- The Johns Hopkins Hospital in Baltimore, United States.
- NYU Langone Medical Facility in New York, U.S.A..
- Necker Health Center in Paris, France.
- Uppsala Teaching Hospital in Uppsala, Sweden.
Results from the research study demonstrate that the imlifidase treatment allowed life-saving transplants in all 18 clients. Graft survival at research conclusion, six months post-transplantation, was 89%.
Therapy of extreme AMR (Planned).
The primary aim of existing AMR therapy is to get rid of the existing donor specific antibodies. In serious AMR plasmapheresis is not adequate to save the kidney given that the magnitude of the antibody feedback goes beyond the capacity of plasmapheresis to clear antibodies.
The finished Phase 1 and also 2 research studies showed that imlifidase cleaves and also inactivates IgG really rapidly and also effectively without any reflux of IgG from the cells. This makes imlifidase extremely fascinating to examine as a therapy for AMR as well as specifically severe AMR.
The risky people for extreme AMR are those that have actually been desensitized as well as hair transplanted with an inappropriate kidney. We are currently investigating the possibility to carry out a scientific research in extreme AMR.
Imlifidase in anti-GBM antibody disease (Ongoing).
In June 2017, the very first patient was treated in a detective initiated Stage 2 research study with imlifidase (IdeS) in anti-GBM antibody illness.The research study (ClinicalTrials.gov identifier NCT03157037) is an open label detective initiated Phase 2 research study in severe anti-GBM condition with Professor Mårten Segelmark at Linköping University Hospital as Sponsor/Coordinating principal investigator. Around 15 clients will be hired to the research study at up to 15 centers in Europe.