Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00121810

Purpose

This 2 arm study will recruit kidney transplant patients receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g bid) and corticosteroids. They will either be randomized to continue this regimen, or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with CellCept and corticosteroids). The effect of these 2 regimens on efficacy, safety and kidney function will be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Kidney Transplantation	Drug: mycophenolate mofetil [CellCept] Drug: Corticosteroids Drug: Calcineurin inhibitors Drug: Sirolimus	Phase IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Sirolimus Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label Study of the Effect of Withdrawal of Cyclosporine or Tacrolimus on Renal Function in Kidney Transplant Recipients Receiving CellCept Plus Corticosteroids

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Mean percentage change in GFR [ Time Frame: 12 months post randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Renal function and GFR. [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
Percentage of patients with late acute biopsy-proven rejection; time to first, and percentage of, acute biopsy-driven rejection episodes; graft loss, death. OIs, malignancies. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Enrollment:	305
Study Start Date:	August 2003

Arms	Assigned Interventions
1: Experimental	Drug: mycophenolate mofetil [CellCept] 1.0-1.5g po bid Drug: Corticosteroids As prescribed Drug: Sirolimus As prescribed
2: Active Comparator	Drug: mycophenolate mofetil [CellCept] 1.0-1.5g po bid 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

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121810

Show 36 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML17140
Study First Received:	July 15, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00121810
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sirolimus
Cyclosporine
Clotrimazole
Miconazole
Tioconazole

Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Cyclosporins

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Antifungal Agents

Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009