The Study of Pharmacokinetics of Levetiracetam in Patients Undergoing Intermittent Hemodialysis

Seizures Clinical Trial

Official title:

The Study of Pharmacokinetics of Levetiracetam in Patients Undergoing Intermittent Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04511676
• Other study ID #: LEV-HD
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: October 10, 2019

Study information

• Verified date: August 2020
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Levetiracetam (LEV) is one of second-generation antiepileptic drugs that has been used to treat partial and generalized epilepsy. LEV is eliminated from the systemic circulation by renal excretion. Therefore, patients with renal impairment may experience a reduced drug excretion and increased adverse drug reactions. Moreover, patients with end-stage renal disease who need dialysis may experience low serum LEV concentration because of drug loss via dialysis. LEV loss via dialysis can cause low serum level of LEV that insufficient for seizure control. The present study was aimed to evaluate pharmacokinetics of LEV in patients undergoing 4 hour-intermittent hemodialysis (IHD). The results of the study may benefit to determine the appropriate LEV initial dose and supplemental dose for patients undergoing IHD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 10, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who were at least 18 years old.

2. Patients who were diagnosed with seizure.

3. Patients who were undergoing intermittent hemodialysis and were treated with intravenous Levetiracetam not less than 2 days

Exclusion Criteria:

1. Patients who were pregnant or lactating

2. Patients who were treated with intravenous Levetiracetam more than once a day

3. Patients who were undergoing sustained low efficiency dialysis (SLED)

4. Patients who have intermittent dialysis duration less than 3 hours

Related Conditions & MeSH terms

• Seizures

Locations

Country	Name	City	State
Thailand	Pharmongkutklao Hospital	Ratchathewi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital	Silpakorn University Faculty of Pharmacy

Country where clinical trial is conducted

Thailand, 

References & Publications (9)

Company-Albir MJ, Ruíz-Ramos J, Solana Altabella A, Marqués-Miñana MR, Vicent C, Poveda JL. Haemodialysis significantly reduces serum levetiracetam levels inducing epileptic seizures: Case report. J Clin Pharm Ther. 2017 Dec;42(6):774-775. doi: 10.1111/jcpt.12568. Epub 2017 May 28. — View Citation

Engelbrecht L, Grobler CJ, Rheeders M. A simple and cost-effective HPLC-UV method for the detection of levetiracetam in plasma/serum of patients with epilepsy. Biomed Chromatogr. 2017 Oct;31(10). doi: 10.1002/bmc.3969. Epub 2017 Apr 20. Review. — View Citation

Jarvie D, Mahmoud SH. Therapeutic Drug Monitoring of Levetiracetam in Select Populations. J Pharm Pharm Sci. 2018;21(1s):149s-176s. doi: 10.18433/jpps30081. Review. — View Citation

Patsalos PN. Clinical pharmacokinetics of levetiracetam. Clin Pharmacokinet. 2004;43(11):707-24. Review. — View Citation

Patsalos PN. Pharmacokinetic profile of levetiracetam: toward ideal characteristics. Pharmacol Ther. 2000 Feb;85(2):77-85. Review. — View Citation

Shiue HJ, Taylor M, Sands KA. Comparison of Levetiracetam Dosing Regimens in End-Stage Renal Disease Patients Undergoing Intermittent Hemodialysis. Ann Pharmacother. 2017 Oct;51(10):862-865. doi: 10.1177/1060028017713294. Epub 2017 Jun 5. — View Citation

Smetana KS, Cook AM, Bastin ML, Oyler DR. Antiepileptic dosing for critically ill adult patients receiving renal replacement therapy. J Crit Care. 2016 Dec;36:116-124. doi: 10.1016/j.jcrc.2016.06.023. Epub 2016 Jul 5. Review. — View Citation

Wieruszewski PM, Kashani KB, Rabinstein AA, Frazee E. Levetiracetam Pharmacokinetics in a Critically Ill Anephric Patient on Intermittent Hemodialysis. Neurocrit Care. 2018 Apr;28(2):243-246. doi: 10.1007/s12028-017-0441-4. — View Citation

Yamamoto J, Toublanc N, Kumagai Y, Stockis A. Levetiracetam pharmacokinetics in Japanese subjects with renal impairment. Clin Drug Investig. 2014 Nov;34(11):819-28. doi: 10.1007/s40261-014-0237-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of Levetiracetam	Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day	Immediately before an initiation of an intermittent hemodialysis session
Primary	Plasma concentration of Levetiracetam	Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day	1 hour after an initiation of an intermittent hemodialysis session
Primary	Plasma concentration of Levetiracetam	Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day	2 hour after an initiation of an intermittent hemodialysis session
Primary	Plasma concentration of Levetiracetam	Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day	3 hour after an initiation of an intermittent hemodialysis session
Primary	Plasma concentration of Levetiracetam	Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day	4 hour after an initiation of an intermittent hemodialysis session
Primary	Plasma concentration of Levetiracetam	Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day	Before an administration of Levetiracetam post-hemodialysis supplemental dose
Primary	Plasma concentration of Levetiracetam	Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day	1 hour after finishing an administration of Levetiracetam post-hemodialysis supplemental dose
Secondary	Plasma concentration of Levetiracetam	Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on non-dialysis day.	Immediately before Levetiracetam administration
Secondary	Plasma concentration of Levetiracetam	Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on non-dialysis day.	1 hour after finishing Levetiracetam administration
Secondary	Number of participants with adverse drug reactions from Levetiracetam	Observed signs and symptoms of Levetiracetam adverse drug reactions after participants were administered with Levetiracetam.	From the first day that participants were included to the study and treated with Levetiracetam until the date of the last point of serum Levetiracetam sampling, assessed up to 3 days