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A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]

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ClinicalTrials.gov Identifier: NCT01022424
Recruitment Status : Completed
First Posted : December 1, 2009
Results First Posted : July 27, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
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 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OPC-41061
Hide Arm/Group Description

Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.

Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol.

Period Title: Overall Study
Started 13
Completed 9
Not Completed 4
Reason Not Completed
Adverse Event             1
Physician Decision             1
eGFR under the withdrawal criteria             2
Arm/Group Title OPC-41061
Hide Arm/Group Description

Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.

Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol.

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
45.6  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
6
  46.2%
Male
7
  53.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 13 participants
13
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.

Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.

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 48, 96, 144, and 192
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 48 Week 96 Week 144 Week 192
Hide Arm/Group Description:

Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.

Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol.

Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.

Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol.

Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.

Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol.

Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.

Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol.

Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.

Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol.

Overall Number of Participants Analyzed 13 12 12 11 10
Median (Inter-Quartile Range)
Unit of Measure: mL
1428
(789 to 4774)
1675
(786 to 4457)
1728
(791 to 4193)
1775
(818 to 4125)
1901
(837 to 3669)
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 48, 96, 144, and 192
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 48 Week 96 Week 144 Week 192
Hide Arm/Group Description:

Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.

Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol.

Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.

Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol.

Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.

Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol.

Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.

Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol.

Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.

Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol.

Overall Number of Participants Analyzed 13 12 12 11 10
Median (Inter-Quartile Range)
Unit of Measure: mL/min/1.73 m2
63.0
(31.0 to 93.0)
60.0
(23.0 to 92.0)
54.0
(22.0 to 113.0)
50.5
(15.0 to 63.0)
51.0
(16.0 to 64.0)
Time Frame Through study completion, an average of 4 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OPC-41061
Hide Arm/Group Description

Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.

Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol.

All-Cause Mortality
OPC-41061
Affected / at Risk (%)
Total   0/13 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
OPC-41061
Affected / at Risk (%)
Total   6/13 (46.15%) 
Eye disorders   
Retinal vein occlusion  1  1/13 (7.69%) 
Gastrointestinal disorders   
Abdominal pain  1  1/13 (7.69%) 
Large intestine polyp  1  1/13 (7.69%) 
General disorders   
Pyrexia  1  1/13 (7.69%) 
Infections and infestations   
Hepatic cyst infection  1  1/13 (7.69%) 
Pyelonephritis  1  1/13 (7.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Uterine leiomyoma  1  1/13 (7.69%) 
Psychiatric disorders   
Alcoholism  1  1/13 (7.69%) 
Vascular disorders   
Hypertension  1  1/13 (7.69%) 
1
Term from vocabulary, MedDRA/JVersion 17.0
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   13/13 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  1/13 (7.69%) 
Nephrogenic anaemia  1  1/13 (7.69%) 
Cardiac disorders   
Sinus tachycardia  1  1/13 (7.69%) 
Supraventricular extrasystoles  1  1/13 (7.69%) 
Ventricular extrasystoles  1  1/13 (7.69%) 
Ear and labyrinth disorders   
Tinnitus  1  1/13 (7.69%) 
Eye disorders   
Angle closure glaucoma  1  1/13 (7.69%) 
Asthenopia  1  1/13 (7.69%) 
Cataract  1  1/13 (7.69%) 
Conjunctival haemorrhage  1  1/13 (7.69%) 
Glaucoma  1  1/13 (7.69%) 
Meibomianitis  1  1/13 (7.69%) 
Ocular hyperaemia  1  1/13 (7.69%) 
Retinal vein occlusion  1  1/13 (7.69%) 
Eyelids pruritus  1  1/13 (7.69%) 
Gastrointestinal disorders   
Abdominal pain  1  2/13 (15.38%) 
Abdominal pain upper  1  1/13 (7.69%) 
Constipation  1  2/13 (15.38%) 
Dental caries  1  2/13 (15.38%) 
Diarrhoea  1  1/13 (7.69%) 
Diverticulum intestinal  1  1/13 (7.69%) 
Enterocolitis  1  1/13 (7.69%) 
Gastritis  1  1/13 (7.69%) 
Gastrooesophageal reflux disease  1  1/13 (7.69%) 
Hiatus hernia  1  2/13 (15.38%) 
Hyperchlorhydria  1  1/13 (7.69%) 
Irritable bowel syndrome  1  1/13 (7.69%) 
Large intestine polyp  1  1/13 (7.69%) 
General disorders   
Chest discomfort  1  1/13 (7.69%) 
Oedema peripheral  1  2/13 (15.38%) 
Pyrexia  1  3/13 (23.08%) 
Thirst  1  6/13 (46.15%) 
Hepatobiliary disorders   
Biliary cirrhosis primary  1  1/13 (7.69%) 
Cholelithiasis  1  1/13 (7.69%) 
Immune system disorders   
Seasonal allergy  1  1/13 (7.69%) 
Infections and infestations   
Acute tonsillitis  1  1/13 (7.69%) 
Bronchitis  1  1/13 (7.69%) 
Conjunctivitis  1  1/13 (7.69%) 
Cystitis  1  2/13 (15.38%) 
Gastroenteritis  1  1/13 (7.69%) 
Herpes zoster  1  1/13 (7.69%) 
Hordeolum  1  1/13 (7.69%) 
Influenza  1  1/13 (7.69%) 
Nasopharyngitis  1  8/13 (61.54%) 
Periodontitis  1  1/13 (7.69%) 
Pertussis  1  1/13 (7.69%) 
Pyelonephritis  1  1/13 (7.69%) 
Hepatic cyst infection  1  1/13 (7.69%) 
Enterocolitis viral  1  1/13 (7.69%) 
Injury, poisoning and procedural complications   
Ligament sprain  1  2/13 (15.38%) 
Radius fracture  1  1/13 (7.69%) 
Rib fracture  1  1/13 (7.69%) 
Investigations   
Alanine aminotransferase increased  1  2/13 (15.38%) 
Aspartate aminotransferase increased  1  1/13 (7.69%) 
Blood antidiuretic hormone increased  1  7/13 (53.85%) 
Blood bilirubin increased  1  1/13 (7.69%) 
Blood creatine phosphokinase increased  1  1/13 (7.69%) 
Blood creatinine increased  1  2/13 (15.38%) 
Blood lactate dehydrogenase increased  1  1/13 (7.69%) 
Blood osmolarity increased  1  1/13 (7.69%) 
Blood triglycerides increased  1  1/13 (7.69%) 
Blood urea increased  1  1/13 (7.69%) 
Electrocardiogram T wave inversion  1  1/13 (7.69%) 
Haematocrit increased  1  1/13 (7.69%) 
Haemoglobin increased  1  1/13 (7.69%) 
Intraocular pressure increased  1  1/13 (7.69%) 
Liver function test abnormal  1  1/13 (7.69%) 
Red blood cell count increased  1  1/13 (7.69%) 
Blood phosphorus decreased  1  1/13 (7.69%) 
Cystatin C increased  1  1/13 (7.69%) 
Urinary casts present  1  1/13 (7.69%) 
Metabolism and nutrition disorders   
Dehydration  1  2/13 (15.38%) 
Gout  1  1/13 (7.69%) 
Hyperuricaemia  1  4/13 (30.77%) 
Decreased appetite  1  1/13 (7.69%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/13 (7.69%) 
Back pain  1  5/13 (38.46%) 
Exostosis of jaw  1  1/13 (7.69%) 
Flank pain  1  1/13 (7.69%) 
Groin pain  1  1/13 (7.69%) 
Joint contracture  1  1/13 (7.69%) 
Pain in extremity  1  1/13 (7.69%) 
Periarthritis  1  2/13 (15.38%) 
Spinal osteoarthritis  1  1/13 (7.69%) 
Intervertebral disc protrusion  1  1/13 (7.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Seborrhoeic keratosis  1  1/13 (7.69%) 
Uterine leiomyoma  1  2/13 (15.38%) 
Nervous system disorders   
Dizziness  1  1/13 (7.69%) 
Headache  1  4/13 (30.77%) 
Hyperaesthesia  1  1/13 (7.69%) 
Psychiatric disorders   
Alcoholism  1  1/13 (7.69%) 
Depression  1  2/13 (15.38%) 
Eating disorder  1  1/13 (7.69%) 
Insomnia  1  1/13 (7.69%) 
Renal and urinary disorders   
Nocturia  1  1/13 (7.69%) 
Pollakiuria  1  4/13 (30.77%) 
Polyuria  1  3/13 (23.08%) 
Renal cyst haemorrhage  1  1/13 (7.69%) 
Renal impairment  1  2/13 (15.38%) 
Reproductive system and breast disorders   
Endometriosis  1  1/13 (7.69%) 
Menopausal symptoms  1  1/13 (7.69%) 
Metrorrhagia  1  1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/13 (7.69%) 
Productive cough  1  1/13 (7.69%) 
Upper respiratory tract inflammation  1  1/13 (7.69%) 
Tonsillar inflammation  1  1/13 (7.69%) 
Oropharyngeal pain  1  1/13 (7.69%) 
Skin and subcutaneous tissue disorders   
Chloasma  1  1/13 (7.69%) 
Dermatitis contact  1  1/13 (7.69%) 
Eczema  1  1/13 (7.69%) 
Haemorrhage subcutaneous  1  1/13 (7.69%) 
Urticaria  1  1/13 (7.69%) 
Urticaria cholinergic  1  1/13 (7.69%) 
Vascular disorders   
Hypertension  1  7/13 (53.85%) 
1
Term from vocabulary, MedDRA/JVersion 17.0
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: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01022424     History of Changes
Other Study ID Numbers: 156-09-003
JapicCTI-090948 ( Other Identifier: JAPIC )
First Submitted: November 27, 2009
First Posted: December 1, 2009
Results First Submitted: October 19, 2017
Results First Posted: July 27, 2018
Last Update Posted: September 11, 2018