PB to Treat Hereditary Nephrogenic Diabetes Insipidus, ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration (SerendipityPB1)
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| ClinicalTrials.gov Identifier: NCT05190744 |
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Recruitment Status :
Recruiting
First Posted : January 13, 2022
Last Update Posted : January 19, 2023
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Sponsor:
Mayo Clinic
Collaborator:
Hopital du Sacre-Coeur de Montreal
Information provided by (Responsible Party):
Fouad T. Chebib, Mayo Clinic
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Brief Summary:
The purpose of this research is to study the effectiveness and safety of the medication PB in slowing the frequent urination related to tolvaptan as long-term treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD), or frequent urination related to inherited nephrogenic diabetes insipidus as an inherited condition or as an acquired condition from prior treatment with lithium.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Autosomal Dominant Polycystic Kidney Disease Nephrogenic Diabetes Insipidus Acquired Nephrogenic Diabetes Insipidus Congenital Nephrogenic Diabetes Insipidus | Drug: PB | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | A Multi-center, Open-Label, Exploratory Study to Assess the Efficacy of PB in Decreasing the Urine Output and Increasing the Urine Osmolality in Patients With Hereditary Nephrogenic Diabetes Insipidus, Patients With Autosomal Dominant Polycystic Kidney Disease Treated With Tolvaptan, And Severely Polyuric Patients With Previous Lithium Administration (Serendipity-PB1) |
| Actual Study Start Date : | September 1, 2022 |
| Estimated Primary Completion Date : | January 2024 |
| Estimated Study Completion Date : | January 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Polyuric subjects with Hereditary Nephrogenic Diabetes Insipidus
Polyuric subjects with hereditary nephrogenic diabetes insipidus with loss of function of AVPR2 or AQP2 will be treated with PB
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Drug: PB
500mg BID followed by 1000mg BID. The dose of PB inducing the maximal increase in urine osmolality will be continued for up to three months providing that no side effects are observed including clinical and laboratory surveillance. |
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Experimental: Polyuric subjects with Autosomal Dominant Polycystic Kidney Disease treated with Tolvaptan
Polyuric subjects with autosomal dominant polycystic kidney disease on chronic tolvaptan treatment will be treated with PB
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Drug: PB
500mg BID followed by 1000mg BID. The dose of PB inducing the maximal increase in urine osmolality will be continued for up to three months providing that no side effects are observed including clinical and laboratory surveillance. |
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Experimental: Polyuric subject secondary to lithium administration
Polyuric subject post lithium administration will receive PB
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Drug: PB
500mg BID followed by 1000mg BID. The dose of PB inducing the maximal increase in urine osmolality will be continued for up to three months providing that no side effects are observed including clinical and laboratory surveillance. |
Primary Outcome Measures :
- Change in urine osmolality [ Time Frame: Baseline, 90 days ]Measured in milliosmoles per kilogram of water (mOsm/kg) from a urine specimen and is a measure of the concentration of osmotically active particles, principally sodium, chloride, potassium, and urea
Secondary Outcome Measures :
- Change in urine output [ Time Frame: Baseline, day 15, day 45, day 75 ]Measured in milliliters per day (ml/day) by 24 hour urine collection
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of nephrogenic diabetes insipidus (NDI) (congenital, tolvaptan-induced, or lithium-induced).
- Morning Uosm < 300 mOsm/kg H2O.
- Participating in tolvaptan arm.
- Males for NDI.
- Autosomal Dominant Polycystic Kidney Disease (ADPKD).
- Lithium-induced NDI.
- GFR ≥ 30 ml/min.
- If hypertensive, blood pressure controlled on antihypertensives (< 130/80 mm Hg) at least 30 days before day 1.
- Capable of providing consent.
- Capable of providing urine samples as dictated by the protocol.
Exclusion Criteria:
- History of acute gout attack in the past 30 days.
- Uncontrolled hyperuricemia or active gout.
- Known urinary retention, urinary incontinence or bladder dysfunction.
- Other significant chronic medical disease (heart failure, diabetes mellitus, liver disease, transient or persistent elevated transaminases.
- History of hepatotoxicity related to tolvaptan.
- Allergy to interventional drug (PB).
- History of persistent hyponatremia.
Information from the National Library of Medicine
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): NCT05190744
Contacts
| Contact: Cameron King | 904-953-4254 | King.Cameron@mayo.edu | |
| Contact: Trinity Hooks | 904-953-3057 | Hooks.Trinity@mayo.edu |
Locations
| United States, Florida | |
| Mayo Clinic | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Clinical Studies Unit 904-953-4254 King.Cameron@mayo.edu | |
| Contact: Trinity Hooks 904-953-3057 Hooks.Trinity@mayo.edu | |
| Principal Investigator: Fouad Chebib, MD | |
Sponsors and Collaborators
Mayo Clinic
Hopital du Sacre-Coeur de Montreal
Investigators
| Principal Investigator: | Fouad Chebib, MD | Mayo Clinic |
Additional Information:
| Responsible Party: | Fouad T. Chebib, Principal Investigator, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT05190744 |
| Other Study ID Numbers: |
21-005437 |
| First Posted: | January 13, 2022 Key Record Dates |
| Last Update Posted: | January 19, 2023 |
| Last Verified: | January 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Fouad T. Chebib, Mayo Clinic:
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Tolvaptan ADPKD Polycystic Kidney Disease NDI Nephrogenic diabetes insipidus Inherited nephrogenic diabetes insipidus |
Diabetes Insipidus Lithium Lithium-induced nephrogenic diabetes insipidus Vasopressin receptor antagonist Tolvaptan-induced aquaresis |
Additional relevant MeSH terms:
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Kidney Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Diabetes Insipidus Diabetes Insipidus, Nephrogenic Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Urologic Diseases Congenital Abnormalities Kidney Diseases, Cystic Abnormalities, Multiple Ciliopathies Genetic Diseases, Inborn Pituitary Diseases |