Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Transplantation |
Drug: mycophenolate mofetil [CellCept] Drug: Corticosteroids Drug: Calcineurin inhibitors Drug: Sirolimus |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Early Calcineurin Inhibitor Withdrawal in Recipients of Primary Renal Allografts Maintained Long-term on Mycophenolate Mofetil (MMF) (CellCept®) and Sirolimus (Rapamune®) |
- Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12 [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
The primary efficacy endpoint was mean percent change in renal function from baseline to 12 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate.
percent change= [(Glomerular Filtration Rate at Month 12-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent.
- Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24 [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
A secondary efficacy endpoint was mean percent change in renal function from baseline to 24 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate.
percent change= [(Glomerular Filtration Rate at Month 24-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent.
- Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24 [ Time Frame: baseline, 6, 12, and 24 months ] [ Designated as safety issue: No ]
Renal allograft function determined by mean percent change from baseline in serum creatinine by treatment group at 6, 12, and 24 months postrandomization.
percent change= [(serum creatinine at Month t-serum creatinine at baseline)/serum creatinine at baseline]*100 percent, where t=6, 12, and 24 months postrandomization.
- Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24 [ Time Frame: baseline 6, 12, and 24 months ] [ Designated as safety issue: No ]
Renal allograft function determined by mean percent change from baseline in calculated creatinine clearance (Cockroft and Gault method) by treatment group at 6, 12, and 24 months postrandomization.
percent change= [(calculated creatinine clearance at Month t - calculated creatinine clearance at baseline)/calculated creatinine clearance at baseline]*100 percent, where t=6, 12, and 24 months postrandomization
- Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation) [ Time Frame: baseline, 6, 12, and 24 months ] [ Designated as safety issue: No ]
Renal allograft function determined by mean percent change from baseline in calculated Glomerular Filtration Rate (Nankivell equation) by treatment group at 6, 12, and 24 months postrandomization.
percent change= [(calculated Glomerular Filtration Rate at Month t - calculated Glomerular Filtration Rate at baseline)/calculated Glomerular Filtration Rate at baseline]*100 percent, where t=6, 12, and 24 months postrandomization.
| Enrollment: | 305 |
| Study Start Date: | August 2003 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: mycophenolate mofetil [CellCept]
1.0-1.5 g oral dose twice daily
Drug: Corticosteroids
As prescribed
Drug: Sirolimus
As prescribed
|
| Active Comparator: 2 |
Drug: mycophenolate mofetil [CellCept]
1.0-1.5 g oral dose twice daily
Drug: Corticosteroids
As prescribed
Drug: Calcineurin inhibitors
As prescribed
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Show 36 Study Locations| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
Additional Information:
No publications provided
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00121810 History of Changes |
| Other Study ID Numbers: | ML17140 |
| Study First Received: | July 15, 2005 |
| Results First Received: | November 18, 2009 |
| Last Updated: | April 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Mycophenolate mofetil Sirolimus Everolimus Mycophenolic Acid Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on October 16, 2012
