MMF and Calcineurin Inhibitor Withdrawal in CAN - Full Text View

Sponsors and Collaborators:	University Hospital Muenster Hoffmann-La Roche
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00204230

Purpose

Prospective, randomised study: Effect of mycophenolatmofetil (MMF) and CNI withdrawal in patients with histologically proven chronic allograft nephropathy Indication: change in immunosuppressive treatment of chronic allograft nephropathy (CAN)after renal transplantation Hypothesis: Antimetabolite MMF is able to stop progression of CAN and improve blood pressure/ metabolic parameters and structural vessel wall changes

Primary Target:effects of CNI withdrawal and MMF on renal function: stabilisation and/or improvement Secondary Targets: Incidence of adverse events Evaluation of the calcineurin inhibitor free MMF treatment effects on blood pressure, lipids, glucose metabolism and on structural and functional vesselwallchanges Method:open prospective, randomized two-tailed, monocentric study

Condition	Intervention
Immunosuppressive Agents Kidney Failure, Chronic Kidney Transplantation	Drug: mycophenolate mofetil (drug)

MedlinePlus related topics: Kidney Failure Kidney Transplantation

Drug Information available for: Mycophenolate Mofetil Mycophenolate mofetil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Controlled Study: Effect of Mycophenolatmofetil in Patients With Histologically Proven Chronic Allograft Nephropathy

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:

course of renal function over 35 weeks

Secondary Outcome Measures:

after 35 weeks of follow up:
incidence of
-acute rejections
-infections
-malignomas
-gastrointestinal disorders
development of blood pressure over 35 weeks
number of antihypertensive drugs
lipid state at entry and after 35 weeks
blood glucose ,HBA1c at entry and after 35 weeks
uric acid at entry and after 35 weeks
Comparison of the development of 1/creatinine within each group at entry and 35 weeks after therapy conversion
area under the curve (AUC) determination of mycophenolic acid (MPA)
vessel wall changes of the carotid arteries IMD , compliance, distensibility and hemodynamic parameters CO, CI, at entry and after after cni withdrawal and MMF addition

Estimated Enrollment:	86
Study Start Date:	October 1999
Estimated Study Completion Date:	September 2002

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent Reduction of graft function: Increase of serum creatinine >= 0,1mg/dl/month in the previous 6 months before start of the study and/or new occurrence or increasing proteinuria in the last 6 months before start of the study Serum creatinine < 4 mg/dl Biopsy within the last 3 months histologically proved chronic allograft nephropathy >=1 year after renal allografting >=5 mg/day Prednisolone or equivalent dose

Exclusion Criteria:

Malignomas Gravidity or Lactation Participation in other studies Severe infections gastrointestinal Ulcer Age <18 and >70 years Leukopenia with less that 3000/dl leucocytes, Anaemia Hb > 9 g/dl Therapy with mycophenolatmofetil in the past 6 months Acute rejections in the past 6 months

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204230

Sponsors and Collaborators

University Hospital Muenster

Hoffmann-La Roche

Investigators

Principal Investigator:

Barbara M Suwelack, PhD

University Hospital

More Information

Publications of Results:

Suwelack B, Gerhardt U, Hohage H. Withdrawal of cyclosporine or tacrolimus after addition of mycophenolate mofetil in patients with chronic allograft nephropathy. Am J Transplant. 2004 Apr;4(4):655-62.

Study ID Numbers:	1
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00204230
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:

Kidney Failure, Chronic
Kidney Transplantation

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Mycophenolate mofetil

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009