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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 September 2022
Main ID:	NCT03487913
Date of registration:	16/03/2018
Prospective Registration:	Yes
Primary sponsor:	Palladio Biosciences
Public title:	The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
Scientific title:	A Phase 2, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
Date of first enrolment:	September 14, 2018
Target sample size:	31
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03487913
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 2

Countries of recruitment
United States

Contacts

Name:	Vicente E Torres, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Mayo Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female, between 18 and 65 years of age at the time of screening

- Estimated glomerular filtration rate (eGFR) = 30 mL/min/1.73 m2 with eGFR calculated
by the CKD EPI equation

- Diagnosed with ADPKD by modified Ravine criteria

- Considered by Investigator to be in good health relative to underlying CKD status and
clinically stable with respect to underlying CKD

Exclusion Criteria:

- Known sensitivity or idiosyncratic reaction to lixivaptan, its related compounds such
as benzazepines (e.g., tolvaptan, conivaptan, benazepril, fenoldopam, or mirtazapine),
or any compound listed as being present in the study formulation

- Women who are pregnant or breast feeding

- Subjects have taken tolvaptan, oral or intravenous antibiotics, or any investigational
drug or used an investigational device within 30 days or 5 half-lives, whichever is
longer, prior to first study dose

- Subject has a transplanted kidney, or absence of a kidney

- Subjects with clinically significant incontinence, overactive bladder, or urinary
retention (e.g., benign prostatic hyperplasia)

- Subjects with clinically significant liver disease, or clinically significant liver
function abnormalities or serology other than that expected for ADPKD with cystic
liver disease at baseline

- Subjects with any clinically significant concomitant disease or condition other than
ADPKD (including treatment for such conditions) that, in the opinion of the
Investigator, could either interfere with the study drug or pose an unacceptable risk
to the subject

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Autosomal Dominant Polycystic Kidney Disease

Intervention(s)

Drug: Lixivaptan

Primary Outcome(s)

Aquaretic tolerability of lixivaptan measured by a tolerability questionnaire relating to the symptom burden of nocturia, urgency, and frequency at Day 7: questions 1, 2, 4, and 6 [Time Frame: Day 7]

Evaluation of the terminal elimination phase half-life (t1/2) of WAY-141624 in ADPKD patients [Time Frame: Day 1 (am) and Day 7 (pm)]

Evaluation of the accumulation ratio for AUC(0-last) (RAUC[0-last]) of lixivaptan in ADPKD patients [Time Frame: Day 7 (am)]

Aquaretic tolerability of lixivaptan measured by a tolerability questionnaire relating to the symptom burden of nocturia, urgency, and frequency at Day 7: questions 3 and 4 [Time Frame: Day 7]

Evaluation of the area under the concentration-time curve from time 0 extrapolated to infinity (AUC[0-inf]) of WAY-141624 in ADPKD patients [Time Frame: Day 1 (am)]

Evaluation of the area under the concentration-time curve from time 0 until the last quantifiable concentration (AUC[0-last]) of WAY-141624 in ADPKD patients [Time Frame: Day 1 (am and pm) and Day 7 (am and pm)]

Evaluation of the apparent terminal elimination rate constant (?Z) of WAY-141624 in ADPKD patients [Time Frame: Day 1 (am) and Day 7 (pm)]

Evaluation of the maximum observed plasma concentration (Cmax) of WAY-141624 in ADPKD patients [Time Frame: Day 1 (am and pm) and Day 7 (am and pm)]

Evaluation of the area under the concentration-time curve from time 0 until 14 hours postdose (AUC[0-14]) of lixivaptan in ADPKD patients [Time Frame: Day 7 (pm)]

Evaluation of the ratio of metabolite AUC(0-14) to parent lixivaptan AUC(0-14) (MRAUC[0-14]) of WAY-138758 in ADPKD patients [Time Frame: Day 7 (pm)]

Evaluation of the area under the concentration-time curve from time 0 extrapolated to infinity (AUC[0-inf]) of lixivaptan in ADPKD patients [Time Frame: Day 1 (am)]

Evaluation of the apparent terminal elimination rate constant (?Z) of lixivaptan in ADPKD patients [Time Frame: Day 1 (am) and Day 7 (pm)]

Evaluation of the area under the concentration-time curve from time 0 until 14 hours postdose (AUC[0-14]) of WAY-138758 in ADPKD patients [Time Frame: Day 7 (pm)]

Evaluation of the apparent terminal elimination rate constant (?Z) of WAY-138451 in ADPKD patients [Time Frame: Day 1 (am) and Day 7 (pm)]

Evaluation of the area under the concentration-time curve from time 0 until 14 hours postdose (AUC[0-14]) of WAY-138451 in ADPKD patients [Time Frame: Day 7 (pm)]

Evaluation of the time to reach maximum plasma concentration (tmax) of WAY-141624 in ADPKD patients [Time Frame: Day 1 (am and pm) and Day 7 (am and pm)]

Evaluation of the area under the concentration-time curve from time 0 until the last quantifiable concentration (AUC[0-last]) of lixivaptan in ADPKD patients [Time Frame: Day 1 (am and pm) and Day 7 (am and pm)]

Evaluation of the apparently systemic clearance after extravascular dosing (CL/F) of lixivaptan in ADPKD patients [Time Frame: Day 1 (am) and Day 7 (am)]

Evaluation of the ratio of metabolite AUC(0-14) to parent lixivaptan AUC(0-14) (MRAUC[0-14]) of WAY-141624 in ADPKD patients [Time Frame: Day 7 (pm)]

Evaluation of the ratio of metabolite AUC(0-14) to parent lixivaptan AUC(0-14) (MRAUC[0-14]) of WAY-138451 in ADPKD patients [Time Frame: Day 7 (pm)]

Number of study participants with clinically significant changes in 12-lead electrocardiograms [Time Frame: Baseline (Day 1) to Day 8 (8 days)]

Evaluation of the area under the concentration-time curve from time 0 extrapolated to infinity (AUC[0-inf]) of WAY-138451 in ADPKD patients [Time Frame: Day 1 (am)]

Evaluation of the maximum observed plasma concentration (Cmax) of WAY-138451 in ADPKD patients [Time Frame: Day 1 (am and pm) and Day 7 (am and pm)]

Evaluation of the time to reach maximum plasma concentration (tmax) of WAY-138758 in ADPKD patients [Time Frame: Day 1 (am and pm) and Day 7 (am and pm)]

Evaluation of the area under the concentration-time curve from time 0 until the last quantifiable concentration (AUC[0-last]) of WAY-138451 in ADPKD patients [Time Frame: Day 1 (am and pm) and Day 7 (am and pm)]

Number of study participants with clinically significant physical examination findings [Time Frame: 35 days]

Evaluation of the ratio of WAY-138451 Cmax to parent lixivaptan Cmax (MRCmax) in ADPKD patients [Time Frame: Day 7 (pm)]

Evaluation of the terminal elimination phase half-life (t1/2) of lixivaptan in ADPKD patients [Time Frame: Day 1 (am) and Day 7 (pm)]

Evaluation of the terminal elimination phase half-life (t1/2) of WAY-138451 in ADPKD patients [Time Frame: Day 1 (am) and Day 7 (pm)]

Evaluation of the terminal elimination phase half-life (t1/2) of WAY-138758 in ADPKD patients [Time Frame: Day 1 (am) and Day 7 (pm)]

Evaluation of the time to reach maximum plasma concentration (tmax) of lixivaptan in ADPKD patients [Time Frame: Day 1 (am and pm) and Day 7 (am and pm)]

Evaluation of the time to reach maximum plasma concentration (tmax) of WAY-138451 in ADPKD patients [Time Frame: Day 1 (am and pm) and Day 7 (am and pm)]

Number of study participants with abnormal clinical laboratory findings (including clinical chemistry, hematology, and urinalysis) [Time Frame: 35 days]

Evaluation of the area under the concentration-time curve from time 0 until the last quantifiable concentration (AUC[0-last]) of WAY-138758 in ADPKD patients [Time Frame: Day 1 (am and pm) and Day 7 (am and pm)]

Evaluation of the ratio of WAY-141624 Cmax to parent lixivaptan Cmax (MRCmax) in ADPKD patients [Time Frame: Day 7 (pm)]

Evaluation of the volume of distribution after extravascular dosing (VZ/F) of lixivaptan in ADPKD patients [Time Frame: Day 1 (am) and Day 7 (am)]

Evaluation of the accumulation ratio for Cmax (RCmax) of lixivaptan in ADPKD patients [Time Frame: Day 7 (am)]

Evaluation of the apparent terminal elimination rate constant (?Z) of WAY-138758 in ADPKD patients [Time Frame: Day 1 (am) and Day 7 (pm)]

Evaluation of the area under the concentration-time curve from time 0 extrapolated to infinity (AUC[0-inf]) of WAY-138758 in ADPKD patients [Time Frame: Day 1 (am)]

Evaluation of the area under the concentration-time curve from time 0 until 14 hours postdose (AUC[0-14]) of WAY-141624 in ADPKD patients [Time Frame: Day 7 (pm)]

Evaluation of the maximum observed plasma concentration (Cmax) of lixivaptan in ADPKD patients [Time Frame: Day 1 (am and pm) and Day 7 (am and pm)]

Evaluation of the maximum observed plasma concentration (Cmax) of WAY-138758 in ADPKD patients [Time Frame: Day 1 (am and pm) and Day 7 (am and pm)]

Evaluation of the ratio of WAY-138758 Cmax to parent lixivaptan Cmax (MRCmax) in ADPKD patients [Time Frame: Day 7 (pm)]

Number of study participants with treatment-emerging adverse events [Time Frame: 35 days]

Number of study participants with clinically significant vital signs [Time Frame: 35 days]

Secondary Outcome(s)

Change from baseline in spot urine osmolality [Time Frame: Baseline (Day -1) and Day 7]

Change from baseline of the estimated glomerular filtration rate (eGFR) [Time Frame: Baseline (Day 1) to end of study (35 days)]

Change from baseline of plasma copeptin [Time Frame: Baseline (Day -1 to end of study (36 days)]

Change from baseline in 24-hour urine output [Time Frame: Baseline (Day -1), Day 1, and Day 7]

Change from baseline in total kidney volume [Time Frame: Baseline (Day -1 to end of study (36 days)]

Change from baseline in serum creatinine [Time Frame: Baseline (Day 1, predose) to end of study (35 days)]

Change from baseline in blood urea nitrogen (BUN) [Time Frame: Baseline (Day 1, predose) to end of study (35 days)]

Change from baseline in liver volume [Time Frame: Baseline (Day -1 to end of study (36 days)]

Secondary ID(s)

PA-102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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