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Intensified Dosing of Cellcept (Mycophenolate Mofetil) in Kidney Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00943228
Recruitment Status : Completed
First Posted : July 22, 2009
Last Update Posted : August 9, 2012
Information provided by (Responsible Party):
Nova Scotia Health Authority

Brief Summary:
The primary objective of this study is to determine whether 4 grams daily of mycophenolate mofetil (MMF) results in a greater proportion of individuals adequately exposed as measured by drug levels (area under the curve of > 40 mg*hr/L).

Condition or disease Intervention/treatment Phase
Acute Rejection of Renal Transplant Drug: mycophenolate mofetil Phase 4

Detailed Description:

Several studies have shown that early exposure to adequate levels of immunosuppression are required to reduce acute rejection rates in kidney transplantation.(1, 2) Our center has shown that early exposure of mycophenolate mofetil (MMF or Cellcept) is associated with acute rejection rates and that many patients are underexposed in the early transplant period.(2) In a recently completed multicenter Canadian (CLEAR) study we found that higher doses of mycophenolate mofetil (MMF 3 grams daily versus 2 grams daily) were associated with better early exposure by day 5 and that this was associated with less rejection but no increase in toxicity.(3) The best cut point that discriminated between low and high rejection rates was a mycophenolic acid (MPA) 12 hour area under the curve (AUC) of 40 mg*hr/L. Patients below this level experienced rejection rates of 50% compared to <16% for those above this level. Even with the higher dose 26% of subjects were inadequately exposed. Since medication adjustments based on drug levels is hampered by steady state conditions and the turn around time of MPA testing we are interested in exploring even higher initial doses of MMF with the aim to maximize the numbers of patients achieving adequate early exposure to MPA.


The primary objective of this study is to determine whether 4 gms daily of MMF results in a greater proportion of individuals adequately exposed as measured by a day 5 MPA AUC of >40 mg*hr/L.

The secondary objectives of this study are to assess the ability of this strategy to achieve target MPA AUC exposure of 40-60 mg*hr/L by day 14 and to determine the distribution of MMF doses that are necessary to achieve this level of exposure. Safety data (hemoglobin and WBC counts, need for further dose changes based on gastrointestinal intolerance, acute rejection, renal function, and wound infection) will be also collected over the first 3 months post transplantation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Intensified Dosing of Cellcept in Kidney Transplantation Trial
Study Start Date : February 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Arm Intervention/treatment
Experimental: mycophenolate mofetil
mycophenolate mofetil 2000mg BID (4g/day) for 14 days, followed by mycophenolate 1000mg BID (2g/day) thereafter
Drug: mycophenolate mofetil
High dose 4gms daily
Other Names:
  • MMF
  • Cellcept

Primary Outcome Measures :
  1. Adequate drug exposure. MPA AUC > 40 mg*hr/l [ Time Frame: First two weeks - 14 days ]

Secondary Outcome Measures :
  1. Gastrointestinal symptoms (nausea, vomiting, abdominal pain, diarrhea). [ Time Frame: First two weeks - 14 days ]
  2. Leukopenia, anemia, thrombocytopenia and infection. [ Time Frame: First two weeks - 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing single organ kidney transplantation.
  • Age > 18 years old.
  • Patients who would normally receive our standard therapy of basiliximab, tacrolimus, MMF and steroids.
  • All patients will be required to sign informed consent.

Exclusion Criteria:

  • Patients will be excluded if they require anti-thymocyte induction therapy, have documented gastroparesis, have known intolerance to MMF, or are prescribed cyclosporine.
  • As a standard policy all women of childbearing age will be informed about the risks of all immunosuppressive drugs on fetal outcomes and will be required to use 2 forms of birth control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00943228

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Canada, Nova Scotia
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Sponsors and Collaborators
Nova Scotia Health Authority
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Principal Investigator: Bryce A Kiberd, MD Dalhousie University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nova Scotia Health Authority Identifier: NCT00943228    
Other Study ID Numbers: IDOC001
First Posted: July 22, 2009    Key Record Dates
Last Update Posted: August 9, 2012
Last Verified: August 2012
Keywords provided by Nova Scotia Health Authority:
Renal transplantation
Adequate exposure
Acute rejection
mycophenolate mofetil
Additional relevant MeSH terms:
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Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action