Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient
This study has been terminated.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00452361
First received: March 23, 2007
Last updated: July 27, 2012
Last verified: July 2012
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Purpose
This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce the severity and/or progression of chronic allograft nephropathy (CAN).
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Transplantation |
Drug: Sirolimus+MMF or MPS or AZA+Steroid Drug: Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid |
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: | A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipient |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- Change in Glomerular Filtration Rate (GFR) Change From Baseline [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.
Secondary Outcome Measures:
- Change in Glomerular Filtration Rate (GFR) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.
- Change in Glomerular Filtration Rate (GFR) [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.
- Change in Glomerular Filtration Rate (GFR) [ Time Frame: Baseline and Week 104 ] [ Designated as safety issue: No ]GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.
- Patient and Graft Survival [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.
- Patient and Graft Survival [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.
- Patient and Graft Survival [ Time Frame: Week 104 ] [ Designated as safety issue: Yes ]Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.
- Change From Baseline in Diastolic Blood Pressure at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]Value at Week 24 minus value at baseline.
- Change From Baseline in Diastolic Blood Pressure at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]Value at Week 52 minus value at baseline.
- Change From Baseline in Diastolic Blood Pressure at Week 104 [ Time Frame: Baseline and Week 104 ] [ Designated as safety issue: No ]Value at Week 104 minus value at baseline.
- Change From Baseline in Systolic Blood Pressure at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]Value at Week 24 minus value at baseline.
- Change From Baseline in Systolic Blood Pressure at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]Value at Week 52 minus value at baseline.
- Change From Baseline in Systolic Blood Pressure at Week 104 [ Time Frame: Baseline and Week 104 ] [ Designated as safety issue: No ]Value at Week 104 minus value at baseline.
- Change From Baseline in the Severity and Progression of Biopsy-Confirmed Chronic Allograft Nephropathy (CAN) at Week 104 [ Time Frame: Baseline and Week 104 ] [ Designated as safety issue: No ]
- Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 52 [ Time Frame: Weeks 52 ] [ Designated as safety issue: No ]
- Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
- Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
| Enrollment: | 31 |
| Study Start Date: | April 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Sirolimus therapy
|
Drug: Sirolimus+MMF or MPS or AZA+Steroid
Corticosteroids will be administered according to local practice, within a daily maintenance dosage range of 2.5 to15 mg for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
|
|
Active Comparator: 2
Calcineurin Inhibitor therapy (either cyclosporine or tacrolimus)
|
Drug: Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid
The maintenance dose of:
Thereafter, at the discretion of the investigator, MMF/MPS or AZA may be:
|
Detailed Description:
This open-label, randomized, parallel-group, comparative, outpatient study will be conducted in multiple centers in Taiwan.
The study will randomize approximately 120 patients. 80 patients will be randomized to the SRL therapy group (conversion from CI- to SRL-based immunosuppression: group A) and 40 patients to the CI therapy group (continued CI therapy: group B).
Dosage and Administration
SRL Therapy: At the time of randomization on day 1, each patient will have been receiving:
- triple therapy with a CI (tacrolimus or CsA) that began at the time of transplantation or within 2 weeks thereafter AND
- corticosteroids corresponding to a dosage range of 2.5 to 15 mg/day for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent for at least 12 weeks before randomization, PLUS
- either MMF (minimum dose 500 mg/day)/MPS (minimum dose 360 mg/day) or AZA (minimum dose 50 mg/day) for at least 12 weeks before randomization.
SRL will be added to the immunosuppressive regimen for Group A. Group B will continue on this CI immunosuppressive regimen.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects must be at least 18 years of age.
- Subjects who are 6 to 60 months after renal transplantation.
- Subjects who have a stable graft function.
Exclusion Criteria:
- Subjects with active major infection, including HIV, decreased platelets, elevated lipids, or multiple organ transplants.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00452361 History of Changes |
| Other Study ID Numbers: | 0468H-101864 |
| Study First Received: | March 23, 2007 |
| Results First Received: | September 24, 2009 |
| Last Updated: | July 27, 2012 |
| Health Authority: | Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Cyclosporins Cyclosporine Sirolimus Everolimus Tacrolimus Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Antibiotics, Antineoplastic Antineoplastic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013