NCT00702715

Comparison of 4.0 mg/kg Sugammadex at 1-2 Post Tetanic Counts (PTC) in Renal or Control Patients (19.4.328)(P05769)

Completed Phase 3 Results posted Last updated 16 May 2017

What this trial tests

Phase 3 trial testing sugammadex in Anesthesia in 69 participants. Completed in 15 March 2010.

Timeline

24 September 2008

Primary endpoint
15 March 2010

15 March 2010

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	69
Start date	24 September 2008
Primary completion	15 March 2010
Estimated completion	15 March 2010

Drugs / interventions tested

• sugammadex — full drug profile →

Conditions studied

• Anesthesia — all drugs for Anesthesia →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Recovery of the T4/T1 Ratio to 0.9. Primary · start of administration of sugammadex to recovery from neuromuscular blockade

Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.

Group	Value	95% CI
Participants With Severe Renal Impairment	205	169 – 248
Participants With Normal Renal Function	112	92 – 138

Time to Recovery of the T4/T1 Ratio to 0.8 Secondary · start of administration of sugammadex to recovery from neuromuscular blockade

Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.

Group	Value	95% CI
Participants With Severe Renal Impairment	169	141 – 203
Participants With Normal Renal Function	90	76 – 107

Time to Recovery of T4/T1 Ratio to 0.7 Secondary · start of administration of sugammadex to recovery from neuromuscular blockade

Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.

Group	Value	95% CI
Participants With Severe Renal Impairment	144	120 – 172
Participants With Normal Renal Function	79	67 – 92

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Participants With Severe Renal Impairment

Serious: 9/35 (26%)

Deaths: —

Participants With Normal Renal Function

Serious: 3/33 (9%)

Deaths: —

Serious adverse events (16 terms)

Reaction	System	Participants With Severe R…	Participants With Normal R…
Wound haemorrhage	Injury, poisoning and procedural complications	—	—
Pneumonia	Infections and infestations	—	—
Subdiaphragmatic abscess	Infections and infestations	—	—
Thrombophlebitis septic	Infections and infestations	—	—
Anastomotic leak	Injury, poisoning and procedural complications	—	—
Incision site haematoma	Injury, poisoning and procedural complications	—	—
Narcotic intoxication	Injury, poisoning and procedural complications	—	—
Seroma	Injury, poisoning and procedural complications	—	—
Wound	Injury, poisoning and procedural complications	—	—
Blood creatinine increased	Investigations	—	—
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Azotaemia	Renal and urinary disorders	—	—
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Extremity necrosis	Vascular disorders	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Participants With Severe R…	Participants With Normal R…
Procedural pain	Injury, poisoning and procedural complications	—	—
Procedural hypotension	Injury, poisoning and procedural complications	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Procedural nausea	Injury, poisoning and procedural complications	—	—
Vomiting	Gastrointestinal disorders	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—
Procedural hypertension	Injury, poisoning and procedural complications	—	—
Neutrophil count increased	Investigations	—	—

Most-reported serious reactions: Wound haemorrhage, Pneumonia, Subdiaphragmatic abscess, Thrombophlebitis septic, Anastomotic leak, Incision site haematoma, Narcotic intoxication, Seroma.

Data from ClinicalTrials.gov NCT00702715 adverse events section.

Sponsor's own description

The current trial was designed to investigate the effects of 4.0 mg.kg-1 of sugammadex on efficacy, safety and pharmacokinetics in subjects with severe renal impairment in comparison to subjects with normal renal function.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy, safety and pharmacokinetics of sugammadex 4 mg kg-1 for reversal of deep neuromuscular blockade in patients with severe renal impairment.
   Panhuizen IF, Gold SJ, Buerkle C, Snoeck MM, et al · · 2015 · cited 43× · PMID 25829395 · DOI 10.1093/bja/aet586