8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD) (NOCTURNE)
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ClinicalTrials.gov Identifier: NCT01451827 |
Recruitment Status
:
Completed
First Posted
: October 14, 2011
Last Update Posted
: June 19, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan MR Drug: Tolvaptan IR Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 178 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
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 Start Date : | October 2011 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Tolvaptan MR 50 mg
Tolvaptan MR 50 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
|
Drug: Tolvaptan MR
50/80 mg capsules
Other Name: OPC-41061
Drug: Placebo
tablet
|
Experimental: Tolvaptan MR 80 mg
Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
|
Drug: Tolvaptan MR
50/80 mg capsules
Other Name: OPC-41061
Drug: Placebo
tablet
|
Experimental: Tolvaptan IR 60/30 mg
Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (AM) and 1 tolvaptan IR 30-mg tablet (PM)
|
Drug: Tolvaptan IR
60/30 mg capsules
Other Name: OPC-41061
Drug: Placebo
tablet
|
Placebo Comparator: Placebo
Placebo MR capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
|
Drug: Placebo
tablet
|
- Percent change in Total Kidney Volume (TKV) [ Time Frame: 3 weeks ]
- Change in total score of the ADPKD-Urinary Impact Scale (UIS) [ Time Frame: 8 weeks ]
- Percent change in Total Kidney Volume (TKV) [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 < 45 mL/min/1.73 m2 calculated based on the most recent historical creatinine during the last 12 months
-
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)
- 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

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): NCT01451827

Study Director: | Frank Czerwiec, M.D., Ph.D. | Otsuka Pharmaceutical Development & Commercialization, Inc. |
Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
ClinicalTrials.gov Identifier: | NCT01451827 History of Changes |
Other Study ID Numbers: |
156-09-290 |
First Posted: | October 14, 2011 Key Record Dates |
Last Update Posted: | June 19, 2014 |
Last Verified: | June 2014 |
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Kidney Disease Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease PKD ADPKD |
Additional relevant MeSH terms:
Kidney Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urologic Diseases Kidney Diseases, Cystic Abnormalities, Multiple Congenital Abnormalities |
Genetic Diseases, Inborn Tolvaptan Antidiuretic Hormone Receptor Antagonists Molecular Mechanisms of Pharmacological Action Natriuretic Agents Physiological Effects of Drugs |