graft function Kidney transplantation
Conditions
Interventions
There are 3 interventions:
1. Interventions to help improve compliance
2. At home monitoring of immunosuppressive drugs
3. Lifestyle program (optional)
1. Monitoring of immunosuppressive drugs via Dr
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - > 1 year after kidney transplantation - Follow-up visits take place in LUMC - Creatinine clearance (CKD-EPI > 25 ml/min) - Immunosuppressive regimen based on tacrolimus - Sufficient mastery of Dutch - Access to and capacity to use the internet. - Availability of a Smart-phone (necessary for blistering) - Informed consent
Exclusion criteria
Exclusion criteria: - No internet access - Creatinine clearance (CKD-EPI * 25 ml/min) - Insufficient knowledge of Dutch language - Proven allergy for iodine contrast
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is reduction in renal function deterioration. Renal function will be determined using iohexol measurement. Iohexol will be injected in the vene of the patient according to the routine clinical protocol, subsequently blood drawing will take place at (3 or 4) preset time points. Concentrations will be measured using HPLC technique at the laboratory. Using the blood concentrations in a pre-developed limited sampling model, an area under the concentration time curve will be determined. Subsequently the GFR is calculated. This procedure is performed at study start and study end. The GFR decline will then be calculated based on these two measurement for all patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Compliance: Improved compliance (frequency of missing a dose (>4 hours after pre-set time), monitored using electronic medication blisters. Original Advagraf blisters will be repacked and provided with a layer consisting of an electronic circuit including microchip. This chip monitors the amount and time of Advagraf capsules being extracted from the blister. Compliance will be defined as the percentage of correct dose intakes. In addition, the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS, De Geest, 2005) will be completed at 3 points in time (baseline, 12 and 24 months). DBS / AUC*s: - Variation in AUC - Frequency of adjusting the dose - Feasibility DBS (patient experience / Logistics) - Addendum 17-06-2019: next to the regular DBS Hemaxis kit, patients will also receive the DBS Mitra Neoteryx kit at the endpoint of the RRFD study in order to calculate the AUC for tacrolimus. The DBS Mitra Neoteryx seems easier to handle, more specifically for patients with reduced vision ability. Clinical: - Other biomarkers renal function / kidney damage - Proteinuria (via alb/creat or protein/creat ratio) - Blood pressure measurements / number anti-hypertensive drugs => blood pressure measurements (at home/hospital) / Dynamap: 3 times 15 min in chair) - BMI (Weight hospital) / Waist-hip ratio Immunological: - DSA (blood withdrawal) - Immunological biomarkers (yet to define) Diabetes / cardiovascular: - Glucose tolerance test - HbA1c => incidence / regulation diabetes (blood withdrawal) - (cholesterol / HDL / LDL/Triglycerides) - Pulse Wave Velocity => cardiovascular - Cardiovascular events (cerebral / cardiac / peripheral) Lifestyle: - Nutritional pattern: sodium, saturated fat, purine-rich, fructose (via questionnaires, 24 hours-urine (sodium, urea) and nutrition module medical dashboard (only intervention group) - activities (through questionnaire) and motion detector (optional). Psychological: - Satisfactio | — |
Countries
Netherlands
Outcome results
None listed