8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Information source: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Autosomal Dominant Polycystic Kidney Disease
Intervention: Tolvaptan MR (Drug); Tolvaptan IR (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Otsuka Pharmaceutical Development & Commercialization, Inc. Official(s) and/or principal investigator(s): Frank Czerwiec, M.D., Ph.D., Study Director, Affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
Summary
The purpose of this study is to compare the short-term effects of two tolvaptan formulations
in patients with ADPKD.
Clinical Details
Official title: A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Placebo-masked, Parallel-group Pilot Trial to Compare the Efficacy, Tolerability, and Safety of Tolvaptan Modified-release and Immediate-release Formulations in Subjects With Autosomal Dominant Polycystic Kidney Disease
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Percent change in Total Kidney Volume (TKV)
Secondary outcome: Change in total score of the ADPKD-Urinary Impact Scale (UIS)Percent change in Total Kidney Volume (TKV)
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age 18 to 50
2. Subjects with:
- BMI between 19 and 35 kg/m2
- diagnosis of ADPKD by modified Ravine criteria:
- family history: 3cysts/kidney if by sonography or 5 by CT or MRI
- Without family history: 10 cysts per kidney
- an eGFR > 45 mL/min/1. 73 m2 by the CKD-EPI equation
3. Subjects not planning to become pregnant willing to comply with birth control
requirements.
4. Subjects must be in good health as determined by screening tests.
5. Subjects providing informed consent and able to comply with all trial requirements.
Exclusion Criteria:
1. Subjects using diuretics within 14 days prior to randomization, or the requirement
for intermittent or constant diuretic use for any reason
2. Subjects who had an eGFR < 45 mL/min/1. 73 m2 calculated based on the most recent
historical creatinine during the last 12 months
3. Subjects with:
- incontinence, overactive bladder, or urinary retention (eg, BPH), meaning
subjects with symptoms of frequent nocturia, as determined by medical history or
urinary urgency should be carefully evaluated to exclude non-ADPKD GU issues
prior to entry.
- liver disease, liver function abnormalities, or serology other than that
expected for ADPKD with cystic liver disease at baseline
- a history of renal surgery or cyst drainage within 6 months of randomization
- blood pressure 150/95 mmHg or < 90/40 mmHg.
- heart rate outside the range of 40 to 90 bpm.
- advanced diabetes with a history of poor control, evidence of significant renal
disease renal cancer, single kidney, or recent renal surgery
- other significant medical history that may interfere with the study objectives
- significant abnormalities in serum sodium concentration (< 135 or > 145 mEq/L)
- a history of drug and/or alcohol abuse within 2 years prior to screening
- clinically significant allergic reactions to tolvaptan or chemically related
structures such as benzazepines (eg, benzazepril, conivaptan, fenoldopam
mesylate, or mirtazapine)
4. Subjects having taken an investigational drug within 30 days preceding randomization
on Day 0
5. Subjects taking medications or having concomitant illnesses likely to confound
endpoint assessments, including taking approved (ie, marketed) therapies for the
purpose of affecting PKD cysts such as tolvaptan, somatostatin agonists (ie,
octreotide, sandostatin), Rapamune (sirolimus), anti-sense RNA therapies, other
vasopressin antagonists (eg, OPC-31260 [mozavaptan] and Vaprisol® [conivaptan]) or
agonists (eg, desmopressin), and cyst reduction surgery
6. Subjects on antihypertensives that have not been on the same antihypertensive regimen
for at least 30 days prior to the first dose of IMP
7. Subjects having contraindications to, or interference with, MRI assessments
8. Subjects with a history of serious mental disorders that, in the opinion of the
investigator, would exclude the subject from participating in this trial
9. Subjects with previous exposure to tolvaptan
Locations and Contacts
Otsuka Investigational Site, Huntsville, Alabama 35802, United States
Otsuka Investigational Site, Mobile, Alabama 36617, United States
Otsuka Investigational Site, Peoria, Arizona 85381, United States
Otsuka Investigational Site, Tempe, Arizona 85284, United States
Otsuka Investigational Site, Los Angeles, California 90025, United States
Otsuka Investigational Site, San Diego, California 92108, United States
Otsuka Investigational Site, Aurora, Colorado 80045, United States
Otsuka Investigational Site 2, Aurora, Colorado 80045, United States
Otsuka Investigational Site, Denver, Colorado 80210, United States
Otsuka Investigational Site, New Haven, Connecticut 06510, United States
Otsuka Investigational Site, Jacksonville, Florida 32216, United States
Otsuka Investigational Site, Melbourne, Florida 32935, United States
Otsuka Investigational Site, Atlanta, Georgia 30322, United States
Otsuka Investigational Site, Augusta, Georgia 30901, United States
Otsuka Investigational Site, Peoria, Illinois 61602, United States
Otsuka Investigational Site, Mishawaka, Indiana 46545, United States
Otsuka Investigational Site, Kansas City, Kansas 66160, United States
Otsuka Investigational Site, Paducah, Kentucky 42003, United States
Otsuka Investigational Site, Shreveport, Louisiana 71101, United States
Otsuka Investigational Site, Baltimore, Maryland 21224, United States
Otsuka Investigational Site, Rockville, Maryland 20850, United States
Otsuka Investigational Site, Boston, Massachusetts 02111, United States
Otsuka Investigational Site, Detroit, Michigan 48236, United States
Otsuka Investigational Site, Rochester, Minnesota 55905, United States
Otsuka Investigational Site, Voorhees, New Jersey 08043, United States
Otsuka Investigational Site, Buffalo, New York 14215, United States
Otsuka Investigational Site, Chapel Hill, North Carolina 27599, United States
Otsuka Investigational Site, Cleveland, Ohio 44106, United States
Otsuka Investigational Site, Bethleham, Pennsylvania 18017, United States
Otsuka Investigational Site, Philadelphia, Pennsylvania 19104, United States
Otsuka Investigational Site, Anderson, South Carolina 29621, United States
Otsuka Investigational Site, Nashville, Tennessee 37205, United States
Otsuka Investigational Site, Arlington, Texas 76015, United States
Otsuka Investigational Site, Mission, Texas 78572, United States
Otsuka Investigational Site, Charlottesville, Virginia 22908, United States
Additional Information
Starting date: October 2011
Last updated: June 12, 2014
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