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A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]

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.
 
ClinicalTrials.gov Identifier: NCT00841568
Recruitment Status : Completed
First Posted : February 11, 2009
Results First Posted : July 27, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Autosomal Dominant Polycystic Kidney Disease
Intervention Drug: OPC-41061
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OPC-41061
Hide Arm/Group Description Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
Period Title: Overall Study
Started 17
Completed 12
Not Completed 5
Reason Not Completed
Adverse Event             1
Death             1
Withdrawal by Subject             2
Creatinine over the withdrawal criteria             1
Arm/Group Title OPC-41061
Hide Arm/Group Description Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
41.8  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
9
  52.9%
Male
8
  47.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 17 participants
17
1.Primary Outcome
Title Total Kidney Volume
Hide Description

Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period.

Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded.

Time Frame Baseline, week 24, 52, 104, and 156
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 24 Week 52 Week 104 Week 156
Hide Arm/Group Description:

Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.

Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period.

Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.

Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period.

Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.

Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period.

Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.

Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period.

Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.

Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period.

Overall Number of Participants Analyzed 17 15 14 12 9
Median (Inter-Quartile Range)
Unit of Measure: mL
1500.5
(781.5 to 5060.1)
1573.1
(770.0 to 5036.6)
1567.9
(774.2 to 4940.3)
1729.4
(858.4 to 4869.0)
1647.7
(868.0 to 2563.8)
2.Primary Outcome
Title Renal Function Test (eGFR)
Hide Description

Individual subject data on eGFR (estimated glomerular filtration rate calculated by Japanese eGFR equation) during trial period.

Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded.

Time Frame Baseline, Week 24, 48, 104, and 156
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 24 Week 52 Week 104 Week 156
Hide Arm/Group Description:

Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.

Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period.

Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.

Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period.

Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.

Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period.

Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.

Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period.

Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.

Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period.

Overall Number of Participants Analyzed 17 15 14 12 12
Median (Inter-Quartile Range)
Unit of Measure: mL/min/1.73m2
63.0
(33 to 108)
64.0
(29 to 115)
64.0
(35 to 122)
58.5
(35 to 114)
59.0
(27 to 103)
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OPC-41061
Hide Arm/Group Description Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
All-Cause Mortality
OPC-41061
Affected / at Risk (%)
Total   1/17 (5.88%) 
Show Serious Adverse Events Hide Serious Adverse Events
OPC-41061
Affected / at Risk (%)
Total   2/17 (11.76%) 
Infections and infestations   
Diverticulitis  1  1/17 (5.88%) 
Nervous system disorders   
Subarachnoid haemorrhage  1  1/17 (5.88%) 
1
Term from vocabulary, MedDRA/JVersion 13.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OPC-41061
Affected / at Risk (%)
Total   17/17 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  1/17 (5.88%) 
Cardiac disorders   
Arrhythmia  1  1/17 (5.88%) 
Palpitations  1  3/17 (17.65%) 
Sinus bradycardia  1  1/17 (5.88%) 
Ear and labyrinth disorders   
Vertigo  1  3/17 (17.65%) 
Eye disorders   
Asthenopia  1  1/17 (5.88%) 
Conjunctival haemorrhage  1  1/17 (5.88%) 
Conjunctivitis  1  1/17 (5.88%) 
Keratitis  1  2/17 (11.76%) 
Eye pruritus  1  1/17 (5.88%) 
Gastrointestinal disorders   
Abdominal discomfort  1  1/17 (5.88%) 
Abdominal distension  1  1/17 (5.88%) 
Abdominal pain  1  1/17 (5.88%) 
Abdominal pain upper  1  1/17 (5.88%) 
Constipation  1  1/17 (5.88%) 
Dental caries  1  3/17 (17.65%) 
Diarrhea  1  2/17 (11.76%) 
Enterocolitis  1  1/17 (5.88%) 
Gastric polyps  1  2/17 (11.76%) 
Gastritis  1  3/17 (17.65%) 
Gastritis erosive  1  1/17 (5.88%) 
Haemorrhoids  1  1/17 (5.88%) 
Irritable bowel syndrome  1  1/17 (5.88%) 
Nausea  1  1/17 (5.88%) 
Periodontal disease  1  1/17 (5.88%) 
Periodontitis  1  1/17 (5.88%) 
Gastrointestinal telangiectasia  1  1/17 (5.88%) 
General disorders   
Chest pain  1  1/17 (5.88%) 
Fatigue  1  1/17 (5.88%) 
Malaise  1  2/17 (11.76%) 
Mass  1  1/17 (5.88%) 
Oedema peripheral  1  1/17 (5.88%) 
Thirst  1  9/17 (52.94%) 
Inflammation  1  1/17 (5.88%) 
Vessel puncture site haematoma  1  1/17 (5.88%) 
Immune system disorders   
Anaphylactic reaction  1  1/17 (5.88%) 
Drug hypersensitivity  1  1/17 (5.88%) 
Seasonal allergy  1  1/17 (5.88%) 
Infections and infestations   
Acute tonsillitis  1  1/17 (5.88%) 
Bronchitis  1  1/17 (5.88%) 
Diverticulitis  1  1/17 (5.88%) 
Hordeolum  1  1/17 (5.88%) 
Influenza  1  1/17 (5.88%) 
Nasopharyngitis  1  13/17 (76.47%) 
Paronychia  1  1/17 (5.88%) 
Pharyngitis  1  2/17 (11.76%) 
Sinusitis  1  2/17 (11.76%) 
Tinea pedis  1  2/17 (11.76%) 
Tonsillitis  1  1/17 (5.88%) 
Urethritis  1  1/17 (5.88%) 
Urinary tract infection  1  1/17 (5.88%) 
Oral herpes  1  1/17 (5.88%) 
Injury, poisoning and procedural complications   
Arthropod sting  1  2/17 (11.76%) 
Clavicle fracture  1  1/17 (5.88%) 
Foot fracture  1  1/17 (5.88%) 
Head injury  1  1/17 (5.88%) 
Laceration  1  1/17 (5.88%) 
Muscle injury  1  1/17 (5.88%) 
Tooth injury  1  1/17 (5.88%) 
Mouth injury  1  1/17 (5.88%) 
Muscle strain  1  2/17 (11.76%) 
Contusion  1  6/17 (35.29%) 
Wound  1  1/17 (5.88%) 
Investigations   
Alanine aminotransferase increased  1  2/17 (11.76%) 
Aspartate aminotransferase increased  1  1/17 (5.88%) 
Blood antidiuretic hormone increased  1  5/17 (29.41%) 
Blood calcium increased  1  1/17 (5.88%) 
Blood cholesterol increased  1  2/17 (11.76%) 
Blood creatine phosphokinase increased  1  1/17 (5.88%) 
Blood creatinine increased  1  2/17 (11.76%) 
Blood glucose increased  1  2/17 (11.76%) 
Blood lactate dehydrogenase increased  1  1/17 (5.88%) 
Blood osmolarity decreased  1  1/17 (5.88%) 
Blood osmolarity increased  1  1/17 (5.88%) 
Blood triglycerides increased  1  2/17 (11.76%) 
Blood uric acid increased  1  4/17 (23.53%) 
Gamma-glutamyltransferase increased  1  1/17 (5.88%) 
Haemoglobin decreased  1  2/17 (11.76%) 
Lymphocyte count decreased  1  1/17 (5.88%) 
Monocyte count increased  1  1/17 (5.88%) 
Neutrophil count increased  1  1/17 (5.88%) 
Red blood cell count decreased  1  1/17 (5.88%) 
White blood cell count decreased  1  1/17 (5.88%) 
Blood phosphorus increased  1  2/17 (11.76%) 
Blood alkaline phosphatase decreased  1  1/17 (5.88%) 
Urine output increased  1  1/17 (5.88%) 
Metabolism and nutrition disorders   
Dehydration  1  3/17 (17.65%) 
Hyperuricaemia  1  2/17 (11.76%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  3/17 (17.65%) 
Arthralgia  1  1/17 (5.88%) 
Lumbar spinal stenosis  1  1/17 (5.88%) 
Neck pain  1  2/17 (11.76%) 
Pain in extremity  1  2/17 (11.76%) 
Spinal osteoarthritis  1  2/17 (11.76%) 
Intervertebral disc protrusion  1  2/17 (11.76%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Skin papilloma  1  1/17 (5.88%) 
Nervous system disorders   
Amnesia  1  1/17 (5.88%) 
Dizziness  1  2/17 (11.76%) 
Glossopharyngeal neuralgia  1  1/17 (5.88%) 
Headache  1  4/17 (23.53%) 
Hyperaesthesia  1  1/17 (5.88%) 
Hypoaesthesia  1  1/17 (5.88%) 
Intracranial aneurysm  1  2/17 (11.76%) 
Migraine  1  1/17 (5.88%) 
Sciatica  1  1/17 (5.88%) 
Subarachnoid haemorrhage  1  1/17 (5.88%) 
Arachnoid cyst  1  1/17 (5.88%) 
Psychiatric disorders   
Adjustment disorder with depressed mood  1  1/17 (5.88%) 
Depression  1  1/17 (5.88%) 
Insomnia  1  1/17 (5.88%) 
Renal and urinary disorders   
Nocturia  1  2/17 (11.76%) 
Pollakiuria  1  2/17 (11.76%) 
Polyuria  1  1/17 (5.88%) 
Renal impairment  1  1/17 (5.88%) 
Reproductive system and breast disorders   
Breast cyst  1  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/17 (5.88%) 
Haemoptysis  1  1/17 (5.88%) 
Rhinorrhoea  1  1/17 (5.88%) 
Upper respiratory tract inflammation  1  2/17 (11.76%) 
Oropharyngeal pain  1  1/17 (5.88%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  2/17 (11.76%) 
Dyshidrosis  1  1/17 (5.88%) 
Eczema  1  2/17 (11.76%) 
Hyperkeratosis  1  1/17 (5.88%) 
Ingrowing nail  1  1/17 (5.88%) 
Pruritus  1  2/17 (11.76%) 
Urticaria  1  1/17 (5.88%) 
Vascular disorders   
Hypertension  1  5/17 (29.41%) 
1
Term from vocabulary, MedDRA/JVersion 13.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Trials
Organization: Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
Layout table for additonal information
Responsible Party: Kyoji Imaoka, Operating Officer, Director, Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00841568     History of Changes
Other Study ID Numbers: 156-05-002
JapicCTI-090690
First Submitted: February 9, 2009
First Posted: February 11, 2009
Results First Submitted: October 17, 2017
Results First Posted: July 27, 2018
Last Update Posted: September 11, 2018