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TRough vs AUC Monitoring of cyclosporine: A randomized comparison of adverse drug reactions in allogeneic stem cell recipients


- candidate number21635
- NTR NumberNTR4996
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-feb-2015
- Secondary IDsNL42166.029.13 
- Public TitleTRough vs AUC Monitoring of cyclosporine: A randomized comparison of adverse drug reactions in allogeneic stem cell recipients
- Scientific TitleTRough vs AUC Monitoring of cyclosporine: A randomized comparison of adverse drug reactions in allogeneic stem cell recipients
- ACRONYMTRAM study
- hypothesisThe number and severity of adverse drug reactions (renal function, nausea and tremor) of cyclosporine using AUC targeted Therapeutic Drug Monitoring as compared to C0 targeted TDM.
- Healt Condition(s) or Problem(s) studiedAllogeneic stem cell transplantation, Cyclosporine, Adverse Drug Events
- Inclusion criteria- Age 18-65 inclusive
- AML, MDS, ALL, MM, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD)
- Planned allogeneic stem cell transplantation
- Related or unrelated donor with a 7/8 or 8/8 HLA match (HLA A, B, C, DRB1) or 9/10 or 10/10 MUD match.
- WHO performance status 0-2
- Written Informed Consent
- Exclusion criteria- Renal dysfunction (serum creatinine > 150 umol/L or clearance < 50 ml/min)
- Patients with active, uncontrolled infection
- Cord Blood transplantation
- Patients with progressive disease in case of MM, CLL, NHL, HL
- Patients with > 5% marrow blasts in case of AML, ALL, CML
- Patients with EMD in case of AML, ALL, CML
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2014
- planned closingdate1-feb-2016
- Target number of participants60
- InterventionsCsA monitoring and dose adjustments will be based on trough levels (arm 1) or abbreviated AUC[0-12] (arm 2)
- Primary outcome- Grade acute kidney injury
- Grade nausea
- Grade in tremor
- Secondary outcomeAdverse drug reactions
- Headache
- Hypertension

Clinical chemical parameters:
- Glucose
- Potassium
- Magnesium
- Total cholesterol
- High-density lipoproteins
- Liver function

Other parameters:
- Grade GVHD
- Minimal residual disease on day 28; 56; 84; 112; 140 ; 168
- Engraftment
- Quality of life (QoL) will be assessed by means of the validated questionnaires.
- Timepoints
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryIn this study the Therapeutic Drug Monitoring of cyclosporine with dried blood spot is investigated in allo SCT recipients. The routine therapeutic drug monitoring of CsA using predose ‘‘trough’’ concentration (C0) is accepted practice. Pharmacokinetic studies in renal transplant patients found that the 12-hour area under the concentration–time curve (AUC[0–12h]) is a very sensitive predictor of acute rejection incidence and graft survival at 1 year post-renal transplant [69] and that it is the best estimate of overall drug exposure, but it is not practical for routine clinical management. Development of the Dry Blood Spot (DBS) sampling have made AUC[0-12h] monitoring more feasible. Patients can perform the fingerprick at home, no invasive procedure is necessary and monitoring at any desired sampling time can be undertaken conveniently. Objective: The number and severity of adverse drug reactions (renal function, nausea and tremor) of cyclosporine using AUC targeted Therapeutic Drug Monitoring as compared to C0 targeted TDM. Study design: Single-blind monocentre intervention study Study population: Patients planned to undergo an allo SCT for malignant hematological disorders and with a related or unrelated 8/8 HLA matched donor are eligible for randomization.
- Main changes (audit trail)
- RECORD2-feb-2015 - 3-apr-2015


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