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Vasopressin Analog
PB for Nephrogenic Diabetes Insipidus (SerendipityPB1 Trial)
Phase 2
Recruiting
Led By Fouad Chebib, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 15, day 45, day 75
Awards & highlights
SerendipityPB1 Trial Summary
This trial will study whether PB can help slow down the frequent urination caused by tolvaptan or nephrogenic diabetes insipidus.
Who is the study for?
This trial is for adults who can consent and have been diagnosed with nephrogenic diabetes insipidus (inherited or from lithium/tolvaptan use), ADPKD, or severe polyuria. They must have a GFR ≥ 30 ml/min, low morning urine concentration, and controlled blood pressure if hypertensive. Excluded are those with chronic diseases like heart failure or liver disease, urinary issues, recent gout attacks, uncontrolled gout/hyperuricemia, drug allergies to PB, or past hepatotoxicity from tolvaptan.Check my eligibility
What is being tested?
The study tests the medication PB's effectiveness in reducing excessive urination in patients with inherited nephrogenic diabetes insipidus (NDI), NDI due to long-term treatment of ADPKD with tolvaptan, or NDI caused by previous lithium therapy.See study design
What are the potential side effects?
Potential side effects of PB may include allergic reactions for those sensitive to it and possibly liver-related issues as seen in past cases with similar treatments. The exact side effects will be monitored throughout the trial.
SerendipityPB1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 15, day 45, day 75
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 15, day 45, day 75
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in urine osmolality
Secondary outcome measures
Change in urine output
SerendipityPB1 Trial Design
3Treatment groups
Experimental Treatment
Group I: Polyuric subjects with Hereditary Nephrogenic Diabetes InsipidusExperimental Treatment1 Intervention
Polyuric subjects with hereditary nephrogenic diabetes insipidus with loss of function of arginine vasopressin receptor 2 (AVPR2) or aquaporin 2 (AQP2) will be treated with PB
Group II: Polyuric subjects with Autosomal Dominant Polycystic Kidney Disease treated with TolvaptanExperimental Treatment1 Intervention
Polyuric subjects with autosomal dominant polycystic kidney disease on chronic tolvaptan treatment will be treated with PB
Group III: Polyuric subject secondary to lithium administrationExperimental Treatment1 Intervention
Polyuric subject post lithium administration will receive PB
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,210 Previous Clinical Trials
3,766,953 Total Patients Enrolled
Hopital du Sacre-Coeur de MontrealOTHER
51 Previous Clinical Trials
12,249 Total Patients Enrolled
Fouad Chebib, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of low sodium levels in your blood that has lasted for a long time.You have a significant long-term health condition like heart failure, diabetes, liver disease, or consistently high liver enzyme levels.Only females are eligible for this study.You have trouble controlling your bladder or have problems with urination.You have been diagnosed with nephrogenic diabetes insipidus (NDI), which can be either genetic or caused by certain medications.You have kidney problems caused by taking lithium.You had a gout attack in the last 30 days.You have uncontrolled high levels of uric acid or currently have gout that is not being managed.Your kidney function is not severely reduced.You are allergic to the study drug PB.Your urine concentration in the morning is less than 300 mOsm/kg H2O.If you have high blood pressure, it must be controlled with medication before the study starts.You have autosomal dominant polycystic kidney disease (ADPKD).You have had liver problems because of taking tolvaptan before.
Research Study Groups:
This trial has the following groups:- Group 1: Polyuric subject secondary to lithium administration
- Group 2: Polyuric subjects with Hereditary Nephrogenic Diabetes Insipidus
- Group 3: Polyuric subjects with Autosomal Dominant Polycystic Kidney Disease treated with Tolvaptan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration sanctioned the use of PB?
"Our team has assessed the safety of PB to be a 2, as this is already in its second stage of trials. There have been some records pointing towards its security, yet it has not demonstrated any efficacy thus far."
Answered by AI
What is the aggregate count of individuals participating in this clinical experiment?
"Affirmative. According to the data presented on clinicaltrials.gov, this medical trial commenced recruiting on September 1st 2022 and is still actively searching for participants as of October 5th 20202. The study requires 20 volunteers from two distinct centres."
Answered by AI
What vacancies remain for participants in this clinical exploration?
"According to clinicaltrials.gov, the research project which was initially posted on September 1st 2022 is in the process of actively recruiting participants. The data has recently been refreshed as of October 5th 2022."
Answered by AI
Who else is applying?
What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
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