Sip-Tego Regimen for Kidney Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment approach for individuals with advanced kidney disease who require a kidney transplant. It tests the safety and effectiveness of the Sip-Tego regimen in helping the body accept a new kidney without rejection. The regimen includes two drugs: Cyclophosphamide, a chemotherapy drug, and Siplizumab, an immunosuppressive drug, involving both the kidney donor and recipient. Individuals with end-stage kidney disease awaiting a kidney transplant from a living donor might be suitable candidates for this study. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative regimen.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those on chronic immunosuppressant medication. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that the Sip-Tego regimen is likely to be safe for humans?
Research has shown that using cyclophosphamide and siplizumab together appears promising based on past studies. Cyclophosphamide, a well-known cancer treatment, can cause side effects like nausea or hair loss, but doctors understand it well. Siplizumab, tested in individuals with kidney transplants, is generally safe, with most people experiencing manageable side effects.
The safety of combining these treatments is still under investigation. As this trial is in the early stages, information about long-term effects or rare side effects remains limited. However, early results are promising enough to warrant continued research. Prospective participants should discuss any concerns with the research team, who can provide more details on what to expect and how they monitor safety.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the Sip-Tego regimen for kidney failure because it combines Cyclophosphamide and Siplizumab, offering a unique approach compared to standard treatments like dialysis or traditional immunosuppressants. Cyclophosphamide is a chemotherapy agent that helps manage immune responses, while Siplizumab is an antibody targeting specific immune cells, potentially reducing transplant rejection rates. This combination could enhance the effectiveness of kidney and bone marrow transplants by precisely modulating the immune system, offering hope for better outcomes and fewer side effects than current therapies.
What evidence suggests that the Sip-Tego regimen might be an effective treatment for kidney failure?
Research has shown that Siplizumab, part of the Sip-Tego treatment plan, may improve kidney function based on similar treatments. In studies, this drug was linked to a lower risk of kidney rejection in transplant patients. Cyclophosphamide, another key component of the treatment, suppresses the immune system, preventing the body from attacking a new kidney. Although specific data for this exact combination in individuals with kidney failure is not yet available, each component has proven effective in related situations. This trial will assess the Sip-Tego regimen's effectiveness in helping the body safely accept the new kidney.35678
Who Is on the Research Team?
Tatsuo Kawai, MD PhD
Principal Investigator
Principal Investigator / Transplant Surgeon
Are You a Good Fit for This Trial?
This trial is for adults with end-stage renal disease who need a kidney transplant and have no prior sensitization. It's not specified, but typically participants should be healthy enough to undergo the procedures and not have conditions that would exclude them from safely participating.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Conditioning Regimen
Participants undergo thymic irradiation, low-dose cyclophosphamide, antibody administration, and bone marrow cell infusion leading up to the renal transplant
Transplantation
Renal transplant is performed using standard surgical techniques
Post-Transplant Monitoring
Participants are monitored for chimerism levels and immunosuppression management
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Siplizumab
Trial Overview
The study tests a new approach called Sip-Tego, which includes receiving both a kidney and bone marrow from the same donor, along with medications (Rituxan, Siplizumab, Cyclophosphamide, Tegoprubart) to encourage immune tolerance of the new organ.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Recipient of kidney and bone marrow transplant
Living donors of kidney and bone marrow transplant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tatsuo Kawai, MD, PhD
Lead Sponsor
Eledon Pharmaceuticals
Industry Sponsor
ITB-Med LLC
Industry Sponsor
Citations
Tolerance Through Mixed Chimerism (Sip-Tego)
Patients with active cancer or those with a high risk of recurrence following the American Transplant Society; Underlying renal disease etiology with a high ...
Siplizumab - an overview | ScienceDirect Topics
A post hoc analysis demonstrated that patients with below-median exposure to tofacitinib had a comparable rejection risk, improved renal function, and similar ...
NCT05669001 | A Study of TCD601 in de Novo Renal ...
... disease (that is, the drug's effectiveness). For example, participants ... therapy in de novo renal transplant patients. Detailed Description. The ...
Safety profile of intravenous and subcutaneous siplizumab ...
Renal allografting is the only long-term alternative to euthanasia in dogs with end-stage kidney disease. The purpose of this study was to ...
TCD601 for Kidney Transplant Tolerance
... effective in patients with more severe illness. After 12 months, there was no significant change in renal function (eGFR) for most patients, and while some ...
Renal Allograft Tolerance Through Mixed Chimerism
The goal is to investigate the safety of the conditioning regimen, and its ability to induce donor/recipient lymphohematopoietic chimerism without Chimerism ...
Randall Sung | Research - Michigan Experts
Sung's research interests include kidney and pancreas transplantation outcomes, deceased donor organ utilization, and transplant program performance evaluation.
Safety Profile, Pharmacokinetics, and Pharmacodynamics ...
Siplizumab has been tested for safety in standard human renal transplant (33) and used as part of a pre-conditioning regimen in humans receiving ...
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