Your session is about to expire
← Back to Search
Tolvaptan for Polycystic Kidney Disease
Study Summary
This trial will test the safety of tolvaptan, a drug used to treat ARPKD, in children.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- Your platelet count is less than 50,000 per microliter.I am taking medications that affect liver enzyme levels.My baby was born at or before 32 weeks and is now between 28 days and less than 12 weeks old.I have an enlarged spleen or high blood pressure in the liver.Your liver function tests show high levels of ALT and AST, which indicate potential liver problems.I am on dialysis or have had a kidney transplant.You have used drugs or alcohol excessively in the last 6 months.My guardian can consent to the trial and I can follow all trial requirements.You have or are at risk of having low blood volume, as determined by the study doctor.You are unable to have your fluid levels checked.You have a serious low blood count, as decided by the doctor.You need help breathing from a machine called a ventilator.I am not pregnant or breastfeeding.I have received or am scheduled for a liver transplant.I am currently taking medication that affects my body's water balance.I am not on medications that could affect the study's results, like tolvaptan or sirolimus.I am on a diuretic that can't be changed after starting tolvaptan.One or both of my parents have kidney cysts.My heart's pumping ability is severely reduced.You have or are at risk of having problems with your sodium and potassium levels, as determined by the doctor.I have an infection that wouldn't interfere with the trial medication schedule.Your blood sodium levels are lower than 130 mmol/L or higher than 145 mmol/L.I am under 18 years old and have been diagnosed with ARPKD.I have a history of not following my prescribed medical treatments consistently.I have not had cholangitis in the last 6 months.I have signs of serious portal hypertension like varices or low platelet count.I have trouble emptying my bladder or have bladder control issues.I have a condition linked to kidney cysts, not including ARPKD.
- Group 1: Tolvaptan Suspension
- Group 2: Tolvaptan Tablets
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are Tolvaptan Tablets safe for human use?
"Tolvaptan Tablets Phase 3 trial data suggests that the medication is effective and safe."
Is Tolvaptan Tablets a new medication?
"Tolvaptan Tablets was first studied in the year 2021 at Cardiology Department. To date there are 63 completed studies. There are currently 3 actively recruiting clinical trials, with a sizeable amount of these trials taking place in Cincinnati, Ohio."
Are enrollees in this experiment required to be eighteen years or older?
"For this particular clinical trial, only patients that fall between the age of 28 days and 18 years old are eligible. Out of the 516 similar trials taking place, 45 involve minors while 461 cater to older adults."
How many trial sites are under the umbrella of this research project?
"This study is currently enrolling 10 patients from medical centres across America, such as Cincinnati Children's Hospital Medical Center and Mayo Clinic - Rochester."
Who meets the requirements to participate in this experiment?
"This clinical trial is for 20 patients who are 28 days to 18 years old with kidney diseases. The following criteria must be met: Male or female subjects between 28 days and less than 18 years of age, with clinical and imaging features that are consistent with a diagnosis of ARPKD with all the following characteristics: nephromegaly (> 2 standard deviations from age-appropriate standard via ultrasound); multiple renal cysts; and a history of oligohydramnios or anhydramnios in utero., Ability for parent/legal guardian to provide written, informed consent prior to initiation of any trial-related procedures, and"
Are patients being recruited for this clinical trial at this time?
"Yes, this clinical trial is still recruiting patients. The primary posting was on July 15th, but the information has been updated as recently as October 4th."
What is the purpose of this clinical trial?
"Research for Tolvaptan Tablets began in 2021 with the first clinical trial sponsored by Otsuka Pharmaceutical Vietnam. After this initial 128 person study, the drug was approved and 3 more trials involving patients from across 8 countries commenced."
How many guinea pigs are participating in this test?
"Yes, the information on clinicaltrials.gov suggests that this clinical trial is currently searching for candidates. The trial was originally posted on 7/15/2022 and was most recently edited on 10/4/2022. The clinical trial is searching for 20 participants between 10 locations"
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger