About Perspective
The study is divided into five periods, lasting five years in total, as described below
Perspective Study Outline
Screening: After informed consent, the study doctor will confirm that the recipient and donor can enter the study.
Conditioning: Starting about 10 days before transplant, a combination of experimental drugs and treatments, including siplizumab, will be given.
Kidney transplantation: The kidney transplant and donor bone marrow infusion will be performed and the standard anti-rejection drugs started.
Post-transplant weaning: If the recipient and kidney are doing well the anti-rejection drugs may be gradually reduced with the goal of stopping by about one year after transplant.
Follow-up: The main study assessment will be at two years with further follow-up until 5 years post-transplant.
Frequently Asked Questions
The aim of this research study is to evaluate if this treatment approach including siplizumab in kidney transplantation, will allow kidney recipients to be free from taking anti-rejection drugs. This is an experimental procedure that has not been tested with this combination of medications before so it is not known if you will benefit from the treatment. It is possible that you will be able to stop your anti-rejection medication after about 1 year. However, it is also possible that you will not be able to stop your anti-rejection medication and you remain on the same medications as if you had not participated. In either case, the information gained may help other patients who are receiving a kidney transplant in the future.
There is no cost to participate in the study, the drugs and procedures that are part of the study will be paid for or provided by the study sponsor, ITB-MED. However you and your insurance will still be responsible for the medical care costs that are normally part of the kidney transplant process.
The combination of siplizumab as well as the drugs and the procedures in the study are not an approved treatment. There are known and unknown risks associated with this combination and these will be explained in detail by the study doctor during the consent process.
During this research study, identifiable information (i.e. “health information”) about the donor and recipient health will be collected. ITB-MED, the sponsor of the research, will protect this information from disclosure to others as required by applicable law. ITB-MED may publish the results of this research; however, they will keep names and other identifying information confidential. A description of this clinical trial is available at the link below, as required by US Law. This web site will not include information that can identify any trial participants. At most, the web site will include a summary of the clinical trial protocol and results.
Study Scientific SummaryA general background to kidney transplantation is provided by the National Kidney Foundation. Click the link below to visit their website:
www.kidney.org