Tacrolimus Regimens for Kidney Transplant Complications
(PTAAK Trial)
Trial Summary
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop your current medications. However, it mentions that participants will be on specific immunosuppressants like Mycophenolate mofetil or mycophenolic sodium, and a prednisone taper or withdrawal protocol. It's best to discuss your current medications with the trial team.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants will be on specific immunosuppressive medications like Mycophenolate mofetil or mycophenolic sodium, along with Tacrolimus. It's best to discuss your current medications with the trial team.
What data supports the idea that Tacrolimus Regimens for Kidney Transplant Complications is an effective drug?
The available research shows that extended-release tacrolimus, like Advagraf or Astagraf XL, is effective for kidney transplant patients. Studies have shown that it provides similar results to the immediate-release version, Prograf, in terms of patient survival and kidney function. Additionally, extended-release tacrolimus improves how well patients stick to their medication schedule, which is important for preventing organ rejection. Compared to another drug, cyclosporine, extended-release tacrolimus has better kidney function outcomes. Overall, it offers the same benefits as the original formulation but with the convenience of once-daily dosing.12345
What data supports the effectiveness of the drug Tacrolimus Regimens for Kidney Transplant Complications?
What safety data exists for tacrolimus regimens in kidney transplant patients?
Safety data for tacrolimus regimens, including extended-release formulations like Advagraf/Astagraf XL and Envarsus XR, show similar safety and efficacy profiles to immediate-release tacrolimus (Prograf). Studies indicate comparable patient and graft survival rates, acute rejection rates, and renal function. Extended-release formulations may improve medication adherence. However, they are not bioequivalent to immediate-release versions, requiring careful dosage adjustments and monitoring. Further research is needed to confirm long-term safety and efficacy across different formulations and patient populations.12346
Is tacrolimus safe for kidney transplant patients?
Tacrolimus, including its extended-release forms like Advagraf and Astagraf XL, has been shown to have a similar safety profile to the immediate-release version (Prograf) in kidney transplant patients. Studies indicate it is generally safe when used as part of an immunosuppressive regimen, although it requires careful monitoring due to its narrow therapeutic index (small margin between effective and harmful doses).12346
Is the drug Extended Release Tacrolimus Tablets a promising treatment for kidney transplant complications?
Yes, Extended Release Tacrolimus Tablets are promising for kidney transplant complications. They offer the benefit of once-daily dosing, which can improve patient adherence to medication. Studies show that this drug is effective in preventing organ rejection and maintaining kidney function, similar to the traditional twice-daily version. It also has a comparable safety profile, making it a reliable option for kidney transplant patients.12345
How is the drug Tacrolimus Regimens for Kidney Transplant Complications different from other treatments?
The extended-release tacrolimus formulations (like Advagraf®/Astagraf XL®) offer the benefit of once-daily dosing, which can improve patient adherence compared to the traditional twice-daily immediate-release tacrolimus. This formulation provides similar efficacy in preventing transplant rejection while potentially offering better renal function and a similar safety profile.12345
What is the purpose of this trial?
The primary purpose of this study is to evaluate the pulse wave velocity and vascular compliance measurements at the beginning and the end of the study while the participants are taking either extended release tacrolimus tablets (known by brand name Envarsus XR®, and also referred to as LCPT in this study) given once-daily each morning after transplantation or immediate release tacrolimus capsules (also known by brand name Prograf® or abbreviation IR-TAC in this study) that are administered twice-daily 12 hours apart after kidney transplantation. Pulse wave velocity and vascular compliance measurements are two non-invasive tests that are used to evaluate how well the blood vessels adapt to each heartbeat. The secondary purpose is to look at the effectiveness and safety of LCPT given once-daily compared to IR-TAC given twice-daily 12 hours apart after kidney transplantation.
Research Team
Roy D Bloom, MD
Principal Investigator
University of Pennsylvania
Eligibility Criteria
This trial is for African American individuals with a BMI ≥19, undergoing their first or second kidney transplant. They must be using certain immunosuppressants and can have Hepatitis B or C. Excluded are those with severe GI issues affecting drug absorption, HIV positive, poor medical adherence history, women not using contraception unless exempted by specific criteria, anyone over 75 years old, recipients of more than two kidney transplants, and those allergic to Tacrolimus.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either immediate release tacrolimus capsules or extended release tacrolimus tablets starting from the first day after kidney transplant
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pulse wave velocity and vascular compliance measurements
Treatment Details
Interventions
- Extended Release Tacrolimus Tablets
- Immediate Release Tacrolimus Capsule
Extended Release Tacrolimus Tablets is already approved in United States for the following indications:
- Prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants
- Prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants
- Prophylaxis of organ rejection in liver, kidney, and heart transplant recipients
- Prophylaxis of organ rejection in kidney transplant recipients
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Who Is Running the Clinical Trial?
Roy D. Bloom, MD
Lead Sponsor
Veloxis Pharmaceuticals
Industry Sponsor