Phase 4
N=305
Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients
Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00121810 ↗Enrolled (actual)
305
Serious AEs
41.2%
Results posted
Feb 2011
Primary outcome: Primary: Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12 — 59.5; 58.8; 24.4; 5.2 percent change — p=0.012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- mycophenolate mofetil [CellCept] (Drug); Corticosteroids (Drug); Calcineurin inhibitors (Drug); Sirolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12 |
59.5; 58.8; 24.4; 5.2 | 0.012 sig |
| SECONDARY Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24 |
59.5; 58.8; 8.6; 3.4 | 0.543 |
| SECONDARY Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24 |
121.1; 124.4; -3.7; 6.6; 6.0; 20.4 | 0.003 sig |
| SECONDARY Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24 |
59.7; 60.5; 7.0; -1.7; 4.4; -2.3 | <0.001 sig |
| SECONDARY Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation) |
71.3; 72.7; 8.3; -0.5; 5.2; -0.9 | <0.001 sig |
Summary
This 2-arm study recruited kidney transplant patients who were receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily) and corticosteroids. They were either randomized to continue this regimen, or CNI therapy was discontinued and replaced by sirolimus therapy (in combination with CellCept and corticosteroids). The effect of these 2 regimens on efficacy, safety and kidney function was evaluated. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- Adult patients 18-75 years of age
- Kidney transplant 30-180 days post-transplantation
- Receipt of cyclosporine or tacrolimus, CellCept, and corticosteroids for greater than 14 days prior to study entry
- No known contraindications to sirolimus
Exclusion Criteria
- Multiple organ transplant recipients or secondary kidney transplant recipients
- Corticosteroid-resistant rejection episode within 90 days prior to study entry or corticosteroid-sensitive rejection episode within 30 days prior to study entry
- More than 1 biopsy-proven episode of acute rejection prior to study entry
- Treated with sirolimus before the study
- Organ transplant or expected organ transplant, other than kidney
- History of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer)
Data sourced from ClinicalTrials.gov (NCT00121810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.