Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT00658333
Eligibility Criteria:
Inclusion criteria:
* Recipients of first or second cadaveric, living unrelated or living related kidney transplant.
* Patients on a reduced daily dose (500mg to 1500mg) of MMF with existing but tolerable and controlled gastrointestinal symptoms.
* Recipients who are at least 4 weeks post renal transplantation with stable renal function.
Exclusion criteria:
* Multi organ transplant or previous transplant with organ other than kidney
* History of GI disorder prior to transplant
* Evidence of GI disorder induced by infection, underlying medical condition, or con med other than MMF
* Modification of GI med or MMF dose within one week
* Evidence of graft rejection, treatment of acute rejection, unstable renal function within 1 week of (baseline) visit
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00658333
Study Brief:
Protocol Section:
NCT00658333