NCT02696499

Treatment of Uremic Pruritus With PA101B

Treatment of Uremic Pruritus With Inhaled PA101B in Patients With End-Stage Renal Disease Requiring Hemodialysis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Patara Pharma · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double blind, placebo-controlled, parallel-arm, multi-center, Phase 2, proof-of-concept efficacy and safety study in patients with end-stage renal disease requiring hemodialysis. The purpose of the study is to determine the efficacy and safety profile of PA101B delivered via eFlow high efficiency nebulizer in patients with uremic pruritus who are symptomatic despite using standard treatments.

Detailed description

The symptom score for determining eligibility will be established during the Screening Period (up to 4 weeks) and eligible patients will be randomly allocated in a 2:1 ratio between the active and placebo arms at the baseline visit (Week 0). During the Treatment Period, clinic visits will occur at the end of Weeks 1, 3, 5 and 7. Following completion of the Treatment Period, patients will enter a 2-week Washout Period in both treatment arms. Routine hemodialysis treatment will continue according to the dialysis unit's standard practice in all patients. Patients will be allowed to continue to use the same daily doses of pre-randomization H1 antihistamines as well as the same daily doses of any other allowed medications throughout the study. Blood samples will be collected for various biomarkers. In a subset of patients, additional blood samples will be collected for pharmacokinetic assessments. Clinical safety assessments will be performed at each clinic visit.

Conditions

• Uremic Pruritus

Interventions

Type	Name	Description
DRUG	PA101B	40 mg PA101B administered via inhalation twice daily for 7 weeks
DRUG	Placebo	Matching placebo administered via inhalation twice daily for 7 weeks

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-08-01
• Completion: 2016-12-01
• First posted: 2016-03-02
• Last updated: 2018-04-20

Locations

13 sites across 1 country: United States