An expanded access record providing Lixivaptan in Polycystic Kidney, sponsored by Palladio Biosciences. No longer available at 1 site in United States. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-10-14.
Sponsored by Palladio Biosciences · Expanded access
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Among 32 studies in Polycystic Kidney Diseases with a site in United States — 9 open to participants now, 9 under way, 1 of them phase 3. Polycystic Kidney Diseases · United States.
Among the 32 studies in Polycystic Kidney Diseases with a site in United States, this one is the only one of another kind, and was the 25th registered.
59 studies on the registry are indexed under Polycystic Kidney Diseases; 12 are open to participants now.
Browse Polycystic Kidney Diseases studies →9 of the 32 studies in Polycystic Kidney Diseases with a site in United States are open now. Recruiting first, the newest first:
Richard Fatica · Sites in United States
Ages 18+
Fetal Care Center, PLLC · Sites in United States
Women only
Ohio State University · Sites in United States
Ages 18–65
Otsuka Pharmaceutical Development & Commercialization, Inc. · Sites in United States, Belgium, Germany and 3 more countries
Ages 28 days–18 yrs
PKD Foundation · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Polycystic Kidney Diseases studies recruiting now, 6 (55%) set no upper age limit and 5 (45%) stop at 75 or younger; 5 take children under 18; 1 takes healthy volunteers.
This study: 15 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 11 · Phase 3 4
First in 2002; this study’s year is marked.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 25 across the 21 interventional studies, 300 across the 10 observational. Of the 21 that completed or were terminated, 10 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 32 have an industry lead sponsor. The 10 most frequent:
Palladio Biosciences is the lead sponsor of 5 studies on the registry; none are open to participants now.
Palladio Biosciences has 1 study filed under Polycystic Kidney Diseases — fewer than ten, so there is no comparison to draw.
2 of the studies in Polycystic Kidney Diseases with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06325644Ohio State UniversityWell-Formulated Ketogenic Diet Polycystic Kidney Disease | 2026-12-01 |
| NCT07454174Richard FaticaMetabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease | 2027-02 |
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Among the 32 studies in Polycystic Kidney Diseases with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Abdominal pain, sometimes severe, is a known symptom of polycystic kidney disease (PKD) related to the cystic expansion. This study will investigate whether the vasopressin V2 receptor antagonist lixivaptan can alleviate intractable pain in a pediatric PKD patient who cannot tolerate the related vasopressin V2 receptor antagonist tolvaptan.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject has been diagnosed with ADPKD by modified Ravine criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daily dose of lixivaptan optimized using a predetermined titration protocol.
Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.
No contact was published for this record. The registry link below has the sponsor’s details.
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