This was a randomized, double-blind, parallel group, placebo-controlled study, in two sequential parts that evaluated the renal safety, tolerability and pharmacokinetics of LHW090 in patients with moderately impaired renal function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
Novartis Investigative Site
Anaheim, California, United States
Novartis Investigative Site
Lakewood, Colorado, United States
Novartis Investigative Site
Miami Lakes, Florida, United States
Number of Patients With Reported Adverse Events Receiving Escalating Doses of LHW090 (Part 1)
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. For LHW090, incidence of AEs by primary organ class presented
Time frame: Adverse events were collected from first dose of study treatment until end of study treatment, (12 days dosing period + 9 days follow up (PART 1) plus 30 days post treatment, up to maximum duration of approximately 20 months
Pharmacokinetics of LHW090/LHV527 (Active Metabolite) in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' Where t is a Defined Time Point After Administration (AUC0-t) (PART 1)
The area under the plasma concentration-time curve from time zero to 24 hours. Area Under the Curve (AUC0-t) after 4 days dosing will be reported for PART 1. LHW090 and LHV527 (its active metabolite)
Time frame: Within 60 minutes prior to dosing, post dose +/- 10 min from greater or equal to 1 hr to 24 hrs.
Number of Patients Who Developed a Renal Event (PART 2)
Patients who developed a renal event will be reported (defined as a ≥0.3 mg/dL increase in serum creatinine from baseline within 24-48 hours post dose )
Time frame: Baseline, within 24 to 48 hours of post-dose weekly for up to 8 weeks
Cmax : Pharmacokinetics of LHW090/LHV527 (Active Metabolite) in Plasma: Observed Maximum Plasma Concentration Following Administration of LHW090 (PART 1/PART 2)
The observed maximum plasma (or serum or blood) concentration following drug administration for PART 1 and PART 2
Time frame: PART 1: within 60 minutes prior to dosing, post dose +/- 10 min from greater or equal to 1 hr to 24 hrs. PART 2: within 60 min +/- 10 min from greater or equal to 1 hr to 8 hours after 4 weeks dosing.
AUC0-t: Pharmacokinetics of LHW090/LHV527 (Active Metabolite)in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' Where t is a Defined Time Point After Administration (PART 2)
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Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
New Orleans, Louisiana, United States
Novartis Investigative Site
Minneapolis, Minnesota, United States
Novartis Investigative Site
Saint Paul, Minnesota, United States
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Elsterwerda, Germany
Novartis Investigative Site
Erlangen, Germany
...and 2 more locations
The area under the plasma concentration-time curve from time zero to 24 hours
Time frame: PART 2: within 60 min +/- 10 min from greater or equal to 1 hr to 8 hours after 4 weeks dosing
Tmax: Pharmacokinetics of LHW090/LHV527 in Plasma: Time to Reach the Maximum Concentration After Administration of LHW090 (PART 1/PART 2)
The time to reach the maximum concentration after drug administration
Time frame: Part 1: within 60 minutes prior to dosing, post dose +/- 10 min from greater or equal to 1 hr to 24 hrs. Part 2: within 60 min +/- 10 min from greater or equal to 1 hr to 8 hours after 4 weeks dosing