Status:
TERMINATED
MMF and Calcineurin Inhibitor Withdrawal in CAN
Lead Sponsor:
University Hospital Muenster
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Immunosuppressive Agents
Kidney Failure, Chronic
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Prospective, randomised study: Effect of mycophenolatmofetil (MMF) and CNI withdrawal in patients with histologically proven chronic allograft nephropathy Indication: change in immunosuppressive treat...
Detailed Description
Prospective, randomised study: Effect of mycophenolatmofetil in patients with histologically proven chronic allograft nephropathy SYNOPSIS Indication: change in treatment to improve the course of ch...
Eligibility Criteria
Inclusion
- 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
- 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
- \-
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
End Date :
September 1 2002
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00204230
Start Date
October 1 1999
End Date
September 1 2002
Last Update
September 20 2005
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