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Vasopressin V2 receptor antagonist

Tolvaptan for Polycystic Kidney Disease

Q: Is Tolvaptan (OPC-41061) a new medication?

Currently, there are 3 ongoing trials for Tolvaptan (OPC-41061), 2 of which have reached Phase 3. Most of these trials are located in <a href="https://www.withpower.com/clinical-trials/washington">Washington</a> D.C., but there are a total of 30 sites running trials for Tolvaptan (OPC-41061) across the United States.

Q: Are we enrolling test subjects at this time?

From what is stated on clinicaltrials.gov, it appears that this particular study is still actively seeking patients. This trial was initially posted on July 1st, 2022 and has undergone its most recent edit on October 4th of the same year.

Q: What are the entry requirements for this trial?

20 individuals with autosomal recessive <a href="https://www.withpower.com/clinical-trials/polycystic-kidney-disease">polycystic kidney disease</a> (arpkd) will be taken into the study, who must meet the following qualifications: Male or female subjects between 28 days and &#x3C; 12 weeks of age, inclusive at the time of enrollment., Nephromegaly (> 2 standard deviations from age appropriate standard via ultrasound), Multiple renal cysts, History of oligohydramnios or anhydramnios, Ability for parent or guardian to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with <a href="https://www.withpower.com/clinical-trials/all">all</a> the requirements of the trial.

Phase 3

Recruiting

Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have clinical and imaging features consistent with a diagnosis of ARPKD with specific characteristics: Nephromegaly, multiple renal cysts, history of oligohydramnios or anhydramnios

Male or female subjects between 28 days and < 12 weeks of age, inclusive at the time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to 2 years of age

Awards & highlights

Study Summary

This trial will test if tolvaptan can help prevent or delay kidney failure in children with ARPKD.

Who is the study for?

This trial is for infants aged between 28 days and less than 12 weeks with autosomal recessive polycystic kidney disease (ARPKD). They should have specific symptoms like enlarged kidneys and multiple cysts. Babies born prematurely or those needing dialysis, with liver issues, low platelets, severe anemia, or electrolyte imbalances can't participate.Check my eligibility

What is being tested?

The study tests if Tolvaptan can help delay the need for dialysis in young children with ARPKD. It aims to see how effective this medication is at managing their kidney function over time.See study design

What are the potential side effects?

Tolvaptan may cause thirst, frequent urination, fatigue, liver enzyme increases leading to potential liver damage, and possible electrolyte imbalance such as low sodium levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have ARPKD with enlarged kidneys, kidney cysts, and a history of low or no amniotic fluid.

Select...

My child is between 28 days and less than 12 weeks old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to 2 years of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to 2 years of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to 2 years of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The percentage of subjects that will have Renal Replacement Therapy (RRT) by 1 year of age.

Secondary outcome measures

Acceptance of the suspension formulation as assessed by a parent questionnaire immediately after and within 15-20 minutes after the first oral dose

Oral cavity

Rate of change of eGFR by Schwartz formula from pre-treatment to after 2 years of treatment

Side effects data

From 2017 Phase 3 trial • 1370 Patients • NCT02160145

17%

Renal pain

11%

Viral upper respiratory tract infection

11%

Hypertension

Upper respiratory tract infection

Headache

Blood creatinine increased

Fatigue

Diarrhoea

Urinary tract infection

Back pain

Polyuria

Haematuria

Oedema peripheral

Hepatic enzyme increased

Alanine aminotransferase increased

Liver function test increased

100%

80%

60%

40%

20%

Study treatment Arm

Tolvaptan (Double-blind Treatment Period)

Placebo (Double-blind Treatment Period)

Tolvaptan (Single-blind Treatment Period)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tolvaptan (OPC-41061)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tolvaptan (OPC-41061)

2014

Completed Phase 3

~1370

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor

246 Previous Clinical Trials

167,029 Total Patients Enrolled

Rosa Real, MDStudy DirectorOtsuka Pharmaceutical Development & Commercialization, Inc.

3 Previous Clinical Trials

107 Total Patients Enrolled

Nataliya Agafonova, MDStudy DirectorOtsuka Pharmaceutical Development & Commercialization, Inc.

1 Previous Clinical Trials

289 Total Patients Enrolled

Media Library

Tolvaptan (Vasopressin V2 receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04786574 — Phase 3

Polycystic Kidney Disease Research Study Groups: Tolvaptan (OPC-41061)

Polycystic Kidney Disease Clinical Trial 2023: Tolvaptan Highlights & Side Effects. Trial Name: NCT04786574 — Phase 3

Tolvaptan (Vasopressin V2 receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04786574 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Tolvaptan (OPC-41061) a new medication?

"Currently, there are 3 ongoing trials for Tolvaptan (OPC-41061), 2 of which have reached Phase 3. Most of these trials are located in Washington D.C., but there are a total of 30 sites running trials for Tolvaptan (OPC-41061) across the United States."

Answered by AI

Are we enrolling test subjects at this time?

"From what is stated on clinicaltrials.gov, it appears that this particular study is still actively seeking patients. This trial was initially posted on July 1st, 2022 and has undergone its most recent edit on October 4th of the same year."

Answered by AI

What are the entry requirements for this trial?

"20 individuals with autosomal recessive polycystic kidney disease (arpkd) will be taken into the study, who must meet the following qualifications: Male or female subjects between 28 days and < 12 weeks of age, inclusive at the time of enrollment., Nephromegaly (> 2 standard deviations from age appropriate standard via ultrasound), Multiple renal cysts, History of oligohydramnios or anhydramnios, Ability for parent or guardian to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial."

Answered by AI

In how many different hospitals is this trial being run today?

"This medical trial is being conducted at six different hospitals, which are Cincinnati Children's Hospital in Cincinnati, Ohio, Mayo Clinic in Rochester, Minnesota, Emory University in Atlanta, Georgia as well 5 additional locations."

Answered by AI

Does this trial break new ground in the medical field?

"Tolvaptan (OPC-41061) is being studied in 3 active clinical trials spread across 14 cities and 8 nations. The first of these studies was conducted in 2021 by Otsuka Pharmaceutical Vietnam. That trial completed its N/A drug approval stage with the help of 128 participants. 63 more studies have been performed since then."

Answered by AI

Are people of all ages eligible for this research project?

"This study includes a very young patient population, with the minimum age for participation being 28 days old and the maximum age of 12 weeks."

Answered by AI

What are some of the risks associated with taking Tolvaptan (OPC-41061)?

"Tolvaptan (OPC-41061) is deemed safe by our team at Power. This is due to the fact that it is a Phase 3 trial, thus there being supportive data for both efficacy and safety."

Answered by AI

How many people are enrolled in this experiment?

"In order to move forward, this study requires 20 individuals that meet the required conditions. These patients can be sourced from multiple locations such as Cincinnati Children's Hospital in Cincinnati, Ohio and Mayo Clinic in Rochester, Minnesota."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

2022. "A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04786574.

All > Kidney Failure > Polycystic Kidney Disease