A Phase 1 interventional study of daptomycin and daptomycin in End-stage Renal Disease and Renal Failure Chronic Requiring Hemodialysis, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-06.
Sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Phase 1, Interventional, and Treatment
The purpose of this study is to determine whether daptomycin at a higher dose given during the last 30 minutes of a dialysis session is equal to a lower dose of daptomycin given after a dialysis session.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 16 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is the lead sponsor of 65 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
9 mg/kg of daptomycin administered during the last 30 minutes of a hemodialysis session.
Drug: daptomycin
Post dialysis dosing
Drug: daptomycin
intradialytic: 9 mg/kg during the last 30 minutes of dialysis
Also known as: Cubicin
6 mg/kg administered after a hemodialysis session
Also known as: Cubicin
Evaluation of Area Under the Curve From Time 0 to Infinity
Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses
Time frame: Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)
Treatment-emergent Adverse Events
Safety was monitored throughout the study, including observation and reports of AEs as well as changes in physical findings, vital signs, ECGs, and laboratory tests.
Time frame: Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).
Maximum Plasma Concentration
Maximum plasma concentration over the entire sampling phase directly obtained from the experimental plasma concentration time data, without interpolation.
Time frame: Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)
Time to Maximum Concentration
Sampling time at which maximum plasma concentration occurred, obtained directly from the experimental plasma concentration time data, without interpolation.
Time frame: Up to 68 hours post dose
Half-life
Apparent terminal half-life.
Time frame: Up to 68 hours post dose
Clearance of Daptomycin
Plasma clearance is dose (µg) divided by area under the concentration versus time curve from time 0 to last quantifiable concentration time.
Time frame: Up to 68 hours post dose
Volume of Distribution
Volume of distribution at steady state (mL) calculated as the product of clearance and mean residence time.
Time frame: Up to 68 hours post dose
| Milestone | Sequence BA | Sequence AB |
|---|---|---|
| Started | 8 | 8 |
| Completed dose 1 | 8 | 7 |
| Completed dose 2 | 6 | 7 |
| Completed | 6 | 7 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Trouble with vein access | 1 | 0 |
| Withdrew: Randomized not treated | 0 | 1 |
Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses
| hr*ug/mL | 6 mg/kg After Hemodialysis (Regimen B) | 9 mg/kg During Hemodialysis (Regimen A) |
|---|---|---|
| Evaluation of Area Under the Curve From Time 0 to Infinity | 1692 (962 to 2524) | 2708 (1719 to 4010) |
Maximum plasma concentration over the entire sampling phase directly obtained from the experimental plasma concentration time data, without interpolation.
| ug/mL | 6 mg/kg After Hemodialysis (Regimen B) | 9 mg/kg During Hemodialysis (Regimen A) |
|---|---|---|
| Maximum Plasma Concentration | 70.5 (35.8 to 104) | 100 (56.5 to 211) |
Sampling time at which maximum plasma concentration occurred, obtained directly from the experimental plasma concentration time data, without interpolation.
| Hours | 6 mg/kg After Hemodialysis (Regimen B) | 9 mg/kg During Hemodialysis (Regimen A) |
|---|---|---|
| Time to Maximum Concentration | 0.50 (0.50 to 1.00) | 0.50 (0.50 to 0.65) |
Apparent terminal half-life.
| Hours | 6 mg/kg After Hemodialysis (Regimen B) | 9 mg/kg During Hemodialysis (Regimen A) |
|---|---|---|
| Half-life | 29.8 (19.7 to 38.1) | 31.1 (21.9 to 45.3) |
Plasma clearance is dose (µg) divided by area under the concentration versus time curve from time 0 to last quantifiable concentration time.
| mL/hr/kg | 6 mg/kg After Hemodialysis (Regimen B) | 9 mg/kg During Hemodialysis (Regimen A) |
|---|---|---|
| Clearance of Daptomycin | 3.54 (2.38 to 6.23) | 3.32 (2.24 to 5.23) |
Volume of distribution at steady state (mL) calculated as the product of clearance and mean residence time.
| mL/kg | 6 mg/kg After Hemodialysis (Regimen B) | 9 mg/kg During Hemodialysis (Regimen A) |
|---|---|---|
| Volume of Distribution | 137 (107 to 221) | 145 (115 to 219) |
Safety was monitored throughout the study, including observation and reports of AEs as well as changes in physical findings, vital signs, ECGs, and laboratory tests.
| participants | 6 mg/kg After Hemodialysis (Regimen B) | 9 mg/kg During Hemodialysis (Regimen A) |
|---|---|---|
| Treatment-emergent Adverse Events | 2 | 3 |
Collected over Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sequence BA | — | 0/8 (0%) | 1/8 (12.5%) |
| Sequence AB | — | 0/7 (0%) | 3/7 (42.9%) |
| Event | Sequence BA | Sequence AB |
|---|---|---|
| ExcoriationInjury, poisoning and procedural complications | 0/8 | 1/7 |
| HeadacheNervous system disorders | 0/8 | 1/7 |
| HypotensionVascular disorders | 1/8 | 1/7 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/8 | 1/7 |
| PyrexiaGeneral disorders | 0/8 | 1/7 |
| Temporomandibular joint syndromeMusculoskeletal and connective tissue disorders | 0/8 | 1/7 |
| Age, Continuous(years) | Sequence BA | Sequence AB | Total |
|---|---|---|---|
| Mean | 51.6 ± 13.19 | 55.3 ± 6.05 | 53.3 ± 10.31 |
| Sex: Female, Male(Participants) | Sequence BA | Sequence AB | Total |
|---|---|---|---|
| Female | 3 | 1 | 4 |
| Male | 5 | 6 | 11 |
Plan to share: Yes — http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)