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8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD) (NOCTURNE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01451827
First Posted: October 14, 2011
Last Update Posted: June 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
October 11, 2011
October 14, 2011
June 19, 2014
October 2011
July 2013   (Final data collection date for primary outcome measure)
Percent change in Total Kidney Volume (TKV) [ Time Frame: 3 weeks ]
Same as current
Complete list of historical versions of study NCT01451827 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
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
The purpose of this study is to compare the short-term effects of two tolvaptan formulations in patients with ADPKD.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Autosomal Dominant Polycystic Kidney Disease
  • Drug: Tolvaptan MR
    50/80 mg capsules
    Other Name: OPC-41061
  • Drug: Tolvaptan IR
    60/30 mg capsules
    Other Name: OPC-41061
  • Drug: Placebo
    tablet
  • Experimental: Tolvaptan MR 50 mg
    Tolvaptan MR 50 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
    Interventions:
    • Drug: Tolvaptan MR
    • Drug: Placebo
  • Experimental: Tolvaptan MR 80 mg
    Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
    Interventions:
    • Drug: Tolvaptan MR
    • Drug: Placebo
  • 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)
    Interventions:
    • Drug: Tolvaptan IR
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Placebo MR capsule and 2 placebo IR tablets (AM) and 1 placebo IR tablet (PM)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
178
July 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01451827
156-09-290
No
Not Provided
Not Provided
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Not Provided
Study Director: Frank Czerwiec, M.D., Ph.D. Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP