This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

MMF and Calcineurin Inhibitor Withdrawal in CAN

This study has been terminated.
Hoffmann-La Roche
Information provided by:
University Hospital Muenster Identifier:
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study: Effect of Mycophenolatmofetil in Patients With Histologically Proven Chronic Allograft Nephropathy

Resource links provided by NLM:

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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00204230

Sponsors and Collaborators
University Hospital Muenster
Hoffmann-La Roche
Principal Investigator: Barbara M Suwelack, PhD University Hospital
  More Information

Publications: Identifier: NCT00204230     History of Changes
Other Study ID Numbers: 1
Study First Received: September 12, 2005
Last Updated: September 12, 2005

Keywords provided by University Hospital Muenster:
Kidney Failure, Chronic
Kidney Transplantation

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Mycophenolate mofetil
Mycophenolic Acid
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents processed this record on August 18, 2017