An interventional study of Everolimus and Sirolimus in Renal Failure, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-21.
Sponsored by Ohio State University · Not applicable, Interventional, and Prevention
This study is being done to compare the effectiveness and safety of two different kidney transplant immunosuppression drugs, Zortress (the study drug) and Rapamune (which is used in the current standard immunosuppression regimen).
Zortress is FDA approved, is used as standard of care at some other institutions, and may also be given as standard of care if it is believed to be the best immunosuppression regimen for a particular kidney transplant recipient. The rationale for testing Zortress vs. Rapamune is to determine which of these drugs is more effective in preventing chronic rejection of the transplanted kidney. Because these two drugs are related to each other there is no current literature addressing the replacement of Rapamune with Zortress in an immunosuppression regimen, therefore the goal of this study is to compare these two immunosuppression drugs.
2,030 studies on the registry are indexed under Renal Insufficiency; 168 are open to participants now.
This study's enrollment of 60 is above the median of 43 across 1,534 interventional studies indexed under Renal Insufficiency.
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Of its 66 completed or terminated interventional studies of FDA-regulated products, 49 (74%) have results posted.
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Zortress will be started on day of transplant and initially dosed at 0.75 mg twice a day (12 hours apart) dosed simultaneously with Neoral.
Drug: Everolimus
Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d.
Drug: Sirolimus
0.75mg twice a day, Orally, starting on day of transplant
Also known as: Zortress
5mg, Orally, starting on day of transplant; decreasing to 3mg
Also known as: Rapamune
Number of Participants With Composite Endpoint of Graft Survival (Non-death Censored) and Biopsy Proven Acute Rejection at 1 Year
The primary objective of this pilot study will be to determine equivalency of Zortress® as compared to Rapamune® when used in our de novo immunosuppression regimen following renal transplantation. The primary endpoint will be a composite endpoint of graft survival (non-death censored) and biopsy proven acute rejection at 1 year. The primary outcome of immunosuppressive protection would be studied in our Thymoglobulin and rapid steroid discontinuation protocol, with "half-dose" Neoral as described above.
Time frame: 1 Year
| Milestone | Zortress (Everolimus) | Rapamune (Sirolimus) |
|---|---|---|
| Started | 41 | 19 |
| Completed | 41 | 19 |
| Not completed | 0 | 0 |
The primary objective of this pilot study will be to determine equivalency of Zortress® as compared to Rapamune® when used in our de novo immunosuppression regimen following renal transplantation. The primary endpoint will be a composite endpoint of graft survival (non-death censored) and biopsy proven acute rejection at 1 year. The primary outcome of immunosuppressive protection would be studied in our Thymoglobulin and rapid steroid discontinuation protocol, with "half-dose" Neoral as described above.
| Participants | Zortress (Everolimus) | Rapamune (Sirolimus) |
|---|---|---|
| graft survival (non-death censored) at 1 year | 40 | 19 |
| biopsy proven acute rejection at 1 year | 38 | 19 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zortress (Everolimus) | 0/41 (0%) | 35/41 (85.4%) | 0/41 (0%) |
| Rapamune (Sirolimus) | 0/19 (0%) | 17/19 (89.5%) | 0/19 (0%) |
| Event | Zortress (Everolimus) | Rapamune (Sirolimus) |
|---|---|---|
| Serious Adverse EffectsGeneral disorders | 35/41 | 17/19 |
Kidney Transplant Patients at Ohio State University Medical Center taking either everolimus or sirolimus.
| Age, Continuous(years) | Zortress (Everolimus) | Rapamune (Sirolimus) | Total |
|---|---|---|---|
| Mean | 49.7 ± 11.9 | 49.5 ± 12.2 | 49.6 ± 11.9 |
| Sex: Female, Male(Participants) | Zortress (Everolimus) | Rapamune (Sirolimus) | Total |
|---|---|---|---|
| Female | 17 | 5 | 22 |
| Male | 24 | 14 | 38 |
| Race and Ethnicity Not Collected(Participants) | Zortress (Everolimus) | Rapamune (Sirolimus) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Everolimus · Sirolimus