Stable renal allograft recipients
Conditions
Interventions
Trade Name: C3 Complex
Product Name: Curcumin
Pharmaceutical Form: Capsule*
Other descriptive name: Curcumin longa
Concentration unit: g gram(s)
Concentration type: not less then
Concentration number:
Sponsors
Department of Nephrology and Renal Transplantation, University Hospitals Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary and secondary renal allograft recipients. Stable (clinically and biochemically) renal transplant patients. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Age < 18 yrs of age. Combined solid organ transplantations. History of medical or surgical diseases of the gastrointestinal and hepato-biliary tract. Recipients with active infectious or inflammatory disease as well as anti-infectious or anti-inflammatory treatment for at least 2 weeks prior to enrolment. Severe hypoalbuminemia (< 25 g/L). Severe anemia (< 8 g/dL). Patients with documented non-compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessing the impact of oral curcumin (Curcuma longa) on mycophenolic acid and metabolite pharmacokinetics in stable renal allograft recipients. ;Secondary Objective: Investigate the role of intestinal uridine-diphosphate-glucuronosyltransferases (UGTs) in in vivo mycophenolic acid disposition. ;Primary end point(s): Differences in mycophenolic acid and metabolite pharmacokinetics in stable renal allograft recipients before and after 7 days administration of Curcumin longa. | — |
Countries
Belgium
Outcome results
None listed