MMF and Calcineurin Inhibitor Withdrawal in CAN

NCT00204230 | Terminated

• 1 other identifier: 1
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Immunosuppressive Agents; Kidney Failure, Chronic; Kidney Transplantation

Keywords

Kidney Failure, Chronic; Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• course of renal function over 35 weeks

Secondary Outcomes (14)

• after 35 weeks of follow up:

• incidence of

• -acute rejections

• -infections

• -malignomas

Interventions

mycophenolate mofetil (drug) DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• Hoffmann-La Roche: collaborator

Related Publications (1)

• 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. doi: 10.1111/j.1600-6143.2004.00404.x.

  PMID: 15023160 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Mycophenolic Acid; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Barbara M Suwelack, PhD

  University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: October 1, 1999
• Study Completion: September 1, 2002
• Last Updated: September 20, 2005

Record last verified: 2005-09