The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03487913 |
Recruitment Status :
Completed
First Posted : April 4, 2018
Last Update Posted : November 30, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autosomal Dominant Polycystic Kidney Disease | Drug: Lixivaptan | Phase 2 |
Therapeutic interventions aimed at counterbalancing the effect of vasopressin and/or normalizing intracellular levels of cAMP may be effective in delaying disease progression in autosomal dominant polycystic kidney disease (ADPKD).
The primary objectives of this study in subjects with ADPKD are:
- To characterize the safety and tolerability of lixivaptan following multiple doses in ADPKD subjects with relatively preserved kidney function (chronic kidney disease CKD1 and CKD2) and moderately impaired renal function (CKD3).
The secondary objectives of this study are:
- To characterize the PK profile of lixivaptan and its major metabolites following multiple doses of lixivaptan in ADPKD subjects with relatively preserved kidney function (CKD1 and CKD2) and moderately impaired renal function (CKD3).
- To characterize the pharmacodynamic effect of lixivaptan on urine output, urine osmolality, total kidney volume, serum vasopressin, and serum creatinine following multiple doses of lixivaptan in ADPKD subjects with relatively preserved kidney function (CKD1 and CKD2) and moderately impaired renal function (CKD3).
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Actual Study Start Date : | September 14, 2018 |
Actual Primary Completion Date : | December 2, 2019 |
Actual Study Completion Date : | February 11, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: High dose
Oral lixivaptan
|
Drug: Lixivaptan
Oral vasopressin V2 receptor antagonist
Other Name: VPA-985 |
Experimental: Low dose
Oral lixivaptan
|
Drug: Lixivaptan
Oral vasopressin V2 receptor antagonist
Other Name: VPA-985 |
- Number of study participants with treatment-emerging adverse events [ Time Frame: 35 days ]The number of study participants who experience treatment-emerging adverse events during the study will be measured.
- Evaluation of the maximum observed plasma concentration of Lixivaptan in ADPKD patients [ Time Frame: 10 days ]The pharmacokinetic parameter Cmax will be used to measure the highest concentration of Lixivaptan in plasma after multiple doses of drug
- Evaluation of the area under the concentration-time curve from time 0 until the last quantifiable concentration of Lixivaptan in ADPKD patients [ Time Frame: 10 days ]The pharmacokinetic parameter AUC0-last for Lixivaptan, calculated using the linear trapezoidal rule for increasing values and the log trapezoidal rule for decreasing values, will be measured and summarized by dose
- Mean change from baseline in trough urine osmolality after 7 days of treatment with Lixivaptan in ADPKD patients [ Time Frame: 7 days ]Spot urine osmolality at trough (mOsm/kg) will be determined for urine samples collected immediately prior to morning dosing for Day 1 (Baseline) and Day 7.
- Mean change from baseline in serum creatinine after 7 days of treatment with Lixivaptan in ADPKD patients [ Time Frame: 7 days ]Serum creatinine (mg/dL) will be determined from plasma samples collected immediately prior to morning dosing for Day 1 (Baseline) and Day 7.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487913
United States, California | |
Palladio Biosciences Clinical Site | |
Los Angeles, California, United States, 90022 | |
United States, Florida | |
Palladio Biosciences Clinical Site | |
Jacksonville, Florida, United States, 32216 | |
Palladio Biosciences Clinical Site | |
Miami, Florida, United States, 33155 | |
Palladio Biosciences Clinical Site | |
Miami, Florida, United States, 33165 | |
Palladio Biosciences Clinical Site | |
Palmetto Bay, Florida, United States, 33157 | |
Palladio Biosciences Clinical Site | |
Tampa, Florida, United States, 33612 | |
United States, Maryland | |
Palladio Biosciences Clinical Site | |
Baltimore, Maryland, United States, 21201 | |
United States, Minnesota | |
Palladio Biosciences Clinical Site | |
Rochester, Minnesota, United States, 55902 | |
United States, Missouri | |
Palladio Biosciences Clinical Site | |
Kansas City, Missouri, United States, 64111 | |
United States, New York | |
Palladio Biosciences Clinical Site | |
Laurelton, New York, United States, 11413 | |
United States, Pennsylvania | |
Palladio Biosciences Clinical Site | |
Indiana, Pennsylvania, United States, 15701 | |
United States, Tennessee | |
Palladio Biosciences Clinical Site | |
Nashville, Tennessee, United States, 66160 | |
United States, Utah | |
Palladio Biosciences Clinical Site | |
Salt Lake City, Utah, United States, 84115 |
Principal Investigator: | Vicente E Torres, MD, PhD | Mayo Clinic |
Responsible Party: | Palladio Biosciences |
ClinicalTrials.gov Identifier: | NCT03487913 |
Other Study ID Numbers: |
PA-102 |
First Posted: | April 4, 2018 Key Record Dates |
Last Update Posted: | November 30, 2020 |
Last Verified: | November 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Arthrogryposis Kidney Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urologic Diseases Joint Diseases Musculoskeletal Diseases |
Muscular Diseases Musculoskeletal Abnormalities Congenital Abnormalities Kidney Diseases, Cystic Abnormalities, Multiple Ciliopathies Genetic Diseases, Inborn |