COLON CLEANSING EFFICACY AND SAFETY OF 1L NER1006 IN PATIENTS WITH MILD TO MODERATE RENAL IMPAIRMENT: POST HOC ANALYSIS OF RANDOMISED PHASE 3 CLINICAL TRIALS

Aims:

Only polyethylene glycol (PEG) bowel preparations are recommended for patients with renal failure. This post hoc analysis of randomised phase 3 clinical trials assessed the colon cleansing efficacy of the first 1L PEG, NER1006, in renally impaired versus non-renally impaired patients.

Methods:

Patients received split dosing regimens of NER1006, either day-before (PM/PM), overnight (PM/AM), or morning-only (AM/AM). Cleansing efficacy was assessed by treatment blinded central readers using the Harefield Cleansing Scale (HCS). The efficacy analysis included patients with a documented renal status and colonoscopy data. Patients were stratified into creatinine clearance rate (CrCl) groups: normal renal function (≥90 mL/min), mild renal insufficiency (≥60 to < 90 mL/min), or moderate renal insufficiency (≥30 to < 60 mL/min). Patients with severe renal insufficiency were excluded.

Results:

Among 1134 randomised patients, 1016 were assessed for efficacy (renal status; 692 mild/moderate, 324 normal). No significant difference was observed in the overall cleansing success rates in mild and moderate versus normal (Table). Safety was assessed in 1028 patients. The types of TEAEs were generally consistent between mild and moderate and normal. The most common TEAEs in all patient groups were gastrointestinal i.e. nausea, vomiting and dehydration. There were numerically more TEAEs in patients with moderate renal insufficiency versus normal. However, this may reflect the patients' disease state.

Tab. 1:

Percentage of NER1006 patients with successful overall colon cleansing using the HCS in patients with renal-impairment vs. normal renal function

Successful overall colon cleansing using the HCS	Mild to moderate renal impairment: CrCl 30-< 90 mL/min	Normal renal function: CrCl 90+ mL/min	P value
MORA PM/AM N = 262	96% (183/190)	97% (69/71)	0.63
MORA AM/AM N = 270	91% (182/200)	91% (62/68)	0.52
DAYB PM/PM N = 236	64% (91/142)	67% (61/91)	0.68
NOCT PM/AM N = 255	92% (147/160)	94% (88/94)	0.69

Conclusions:

The current efficacy and safety findings support the use of NER1006 (PLENVU) as a bowel preparation in patients with mild to moderate renal impairment.