Phase 2
N=177
8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Autosomal Dominant Polycystic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01451827 ↗Enrolled (actual)
177
Serious AEs
3.4%
Results posted
Aug 2018
Primary outcome: Primary: Percent Change From Baseline in Total Kidney Volume (TKV) at Week 3 — -2.46; -2.55; -1.17; 0.09 Percentage change — p=0.0127
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tolvaptan MR (Drug); Tolvaptan IR (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Total Kidney Volume (TKV) at Week 3 |
-2.46; -2.55; -1.17; 0.09 | 0.0127 sig |
| SECONDARY Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS) |
0.74; 0.82; 0.99; 0.10; 0.69; 0.66 | 0.0002 sig |
| SECONDARY Percent Change From Baseline in TKV at Week 8. |
-2.04; -2.02; -0.08; 2.13 | 0.0209 sig |
Summary
The purpose of this study is to compare the short-term effects of two tolvaptan formulations in patients with ADPKD.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 50
- 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
- Subjects not planning to become pregnant willing to comply with birth control requirements.
- Subjects must be in good health as determined by screening tests.
- Subjects providing informed consent and able to comply with all trial requirements.
Exclusion Criteria
- Subjects using diuretics within 14 days prior to randomization, or the requirement for intermittent or constant diuretic use for any reason
- Subjects who had an eGFR 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)
- Subjects having taken an investigational drug within 30 days preceding randomization on Day 0
- 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
- Subjects on antihypertensives that have not been on the same antihypertensive regimen for at least 30 days prior to the first dose of IMP
- Subjects having contraindications to, or interference with, MRI assessments
- Subjects with a history of serious mental disorders that, in the opinion of the investigator, would exclude the subject from participating in this trial
- Subjects with previous exposure to tolvaptan
Data sourced from ClinicalTrials.gov (NCT01451827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.