Trial Outcomes & Findings for A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001] (NCT NCT00841568)
NCT ID: NCT00841568
Last Updated: 2018-09-11
Results Overview
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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Baseline, week 24, 52, 104, and 156
Results posted on
2018-09-11
Participant Flow
Participant milestones
| Measure |
OPC-41061
Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
OPC-41061
Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Creatinine over the withdrawal criteria
|
1
|
Baseline Characteristics
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
Baseline characteristics by cohort
| Measure |
OPC-41061
n=17 Participants
Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 8.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Region of Enrollment
Japan
|
17 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 24, 52, 104, and 156Individual 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.
Outcome measures
| Measure |
Baseline
n=17 Participants
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.
|
Week 24
n=15 Participants
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.
|
Week 52
n=14 Participants
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.
|
Week 104
n=12 Participants
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.
|
Week 156
n=9 Participants
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.
|
|---|---|---|---|---|---|
|
Total Kidney Volume
|
1500.5 mL
Interval 781.5 to 5060.1
|
1573.1 mL
Interval 770.0 to 5036.6
|
1567.9 mL
Interval 774.2 to 4940.3
|
1729.4 mL
Interval 858.4 to 4869.0
|
1647.7 mL
Interval 868.0 to 2563.8
|
PRIMARY outcome
Timeframe: Baseline, Week 24, 48, 104, and 156Individual 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.
Outcome measures
| Measure |
Baseline
n=17 Participants
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.
|
Week 24
n=15 Participants
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.
|
Week 52
n=14 Participants
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.
|
Week 104
n=12 Participants
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.
|
Week 156
n=12 Participants
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.
|
|---|---|---|---|---|---|
|
Renal Function Test (eGFR)
|
63.0 mL/min/1.73m2
Interval 33.0 to 108.0
|
64.0 mL/min/1.73m2
Interval 29.0 to 115.0
|
64.0 mL/min/1.73m2
Interval 35.0 to 122.0
|
58.5 mL/min/1.73m2
Interval 35.0 to 114.0
|
59.0 mL/min/1.73m2
Interval 27.0 to 103.0
|
Adverse Events
OPC-41061
Serious events: 2 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
OPC-41061
n=17 participants at risk
Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
|
|---|---|
|
Infections and infestations
Diverticulitis
|
5.9%
1/17 • 3 years
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
5.9%
1/17 • 3 years
|
Other adverse events
| Measure |
OPC-41061
n=17 participants at risk
Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
1/17 • 3 years
|
|
Cardiac disorders
Arrhythmia
|
5.9%
1/17 • 3 years
|
|
Cardiac disorders
Palpitations
|
17.6%
3/17 • 3 years
|
|
Cardiac disorders
Sinus bradycardia
|
5.9%
1/17 • 3 years
|
|
Ear and labyrinth disorders
Vertigo
|
17.6%
3/17 • 3 years
|
|
Eye disorders
Asthenopia
|
5.9%
1/17 • 3 years
|
|
Eye disorders
Conjunctival haemorrhage
|
5.9%
1/17 • 3 years
|
|
Eye disorders
Conjunctivitis
|
5.9%
1/17 • 3 years
|
|
Eye disorders
Keratitis
|
11.8%
2/17 • 3 years
|
|
Eye disorders
Eye pruritus
|
5.9%
1/17 • 3 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.9%
1/17 • 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
1/17 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • 3 years
|
|
Gastrointestinal disorders
Dental caries
|
17.6%
3/17 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
11.8%
2/17 • 3 years
|
|
Gastrointestinal disorders
Enterocolitis
|
5.9%
1/17 • 3 years
|
|
Gastrointestinal disorders
Gastric polyps
|
11.8%
2/17 • 3 years
|
|
Gastrointestinal disorders
Gastritis
|
17.6%
3/17 • 3 years
|
|
Gastrointestinal disorders
Gastritis erosive
|
5.9%
1/17 • 3 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.9%
1/17 • 3 years
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
5.9%
1/17 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • 3 years
|
|
Gastrointestinal disorders
Periodontal disease
|
5.9%
1/17 • 3 years
|
|
Gastrointestinal disorders
Periodontitis
|
5.9%
1/17 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal telangiectasia
|
5.9%
1/17 • 3 years
|
|
General disorders
Chest pain
|
5.9%
1/17 • 3 years
|
|
General disorders
Fatigue
|
5.9%
1/17 • 3 years
|
|
General disorders
Malaise
|
11.8%
2/17 • 3 years
|
|
General disorders
Mass
|
5.9%
1/17 • 3 years
|
|
General disorders
Oedema peripheral
|
5.9%
1/17 • 3 years
|
|
General disorders
Thirst
|
52.9%
9/17 • 3 years
|
|
General disorders
Inflammation
|
5.9%
1/17 • 3 years
|
|
General disorders
Vessel puncture site haematoma
|
5.9%
1/17 • 3 years
|
|
Immune system disorders
Anaphylactic reaction
|
5.9%
1/17 • 3 years
|
|
Immune system disorders
Drug hypersensitivity
|
5.9%
1/17 • 3 years
|
|
Immune system disorders
Seasonal allergy
|
5.9%
1/17 • 3 years
|
|
Infections and infestations
Acute tonsillitis
|
5.9%
1/17 • 3 years
|
|
Infections and infestations
Bronchitis
|
5.9%
1/17 • 3 years
|
|
Infections and infestations
Diverticulitis
|
5.9%
1/17 • 3 years
|
|
Infections and infestations
Hordeolum
|
5.9%
1/17 • 3 years
|
|
Infections and infestations
Influenza
|
5.9%
1/17 • 3 years
|
|
Infections and infestations
Nasopharyngitis
|
76.5%
13/17 • 3 years
|
|
Infections and infestations
Paronychia
|
5.9%
1/17 • 3 years
|
|
Infections and infestations
Pharyngitis
|
11.8%
2/17 • 3 years
|
|
Infections and infestations
Sinusitis
|
11.8%
2/17 • 3 years
|
|
Infections and infestations
Tinea pedis
|
11.8%
2/17 • 3 years
|
|
Infections and infestations
Tonsillitis
|
5.9%
1/17 • 3 years
|
|
Infections and infestations
Urethritis
|
5.9%
1/17 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • 3 years
|
|
Infections and infestations
Oral herpes
|
5.9%
1/17 • 3 years
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
11.8%
2/17 • 3 years
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
5.9%
1/17 • 3 years
|
|
Injury, poisoning and procedural complications
Foot fracture
|
5.9%
1/17 • 3 years
|
|
Injury, poisoning and procedural complications
Head injury
|
5.9%
1/17 • 3 years
|
|
Injury, poisoning and procedural complications
Laceration
|
5.9%
1/17 • 3 years
|
|
Injury, poisoning and procedural complications
Muscle injury
|
5.9%
1/17 • 3 years
|
|
Injury, poisoning and procedural complications
Tooth injury
|
5.9%
1/17 • 3 years
|
|
Injury, poisoning and procedural complications
Mouth injury
|
5.9%
1/17 • 3 years
|
|
Injury, poisoning and procedural complications
Muscle strain
|
11.8%
2/17 • 3 years
|
|
Injury, poisoning and procedural complications
Contusion
|
35.3%
6/17 • 3 years
|
|
Injury, poisoning and procedural complications
Wound
|
5.9%
1/17 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
2/17 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
1/17 • 3 years
|
|
Investigations
Blood antidiuretic hormone increased
|
29.4%
5/17 • 3 years
|
|
Investigations
Blood calcium increased
|
5.9%
1/17 • 3 years
|
|
Investigations
Blood cholesterol increased
|
11.8%
2/17 • 3 years
|
|
Investigations
Blood creatine phosphokinase increased
|
5.9%
1/17 • 3 years
|
|
Investigations
Blood creatinine increased
|
11.8%
2/17 • 3 years
|
|
Investigations
Blood glucose increased
|
11.8%
2/17 • 3 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.9%
1/17 • 3 years
|
|
Investigations
Blood osmolarity decreased
|
5.9%
1/17 • 3 years
|
|
Investigations
Blood osmolarity increased
|
5.9%
1/17 • 3 years
|
|
Investigations
Blood triglycerides increased
|
11.8%
2/17 • 3 years
|
|
Investigations
Blood uric acid increased
|
23.5%
4/17 • 3 years
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.9%
1/17 • 3 years
|
|
Investigations
Haemoglobin decreased
|
11.8%
2/17 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
5.9%
1/17 • 3 years
|
|
Investigations
Monocyte count increased
|
5.9%
1/17 • 3 years
|
|
Investigations
Neutrophil count increased
|
5.9%
1/17 • 3 years
|
|
Investigations
Red blood cell count decreased
|
5.9%
1/17 • 3 years
|
|
Investigations
White blood cell count decreased
|
5.9%
1/17 • 3 years
|
|
Investigations
Blood phosphorus increased
|
11.8%
2/17 • 3 years
|
|
Investigations
Blood alkaline phosphatase decreased
|
5.9%
1/17 • 3 years
|
|
Investigations
Urine output increased
|
5.9%
1/17 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
17.6%
3/17 • 3 years
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
11.8%
2/17 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.6%
3/17 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
5.9%
1/17 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.8%
2/17 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.8%
2/17 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
11.8%
2/17 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
11.8%
2/17 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
5.9%
1/17 • 3 years
|
|
Nervous system disorders
Amnesia
|
5.9%
1/17 • 3 years
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • 3 years
|
|
Nervous system disorders
Glossopharyngeal neuralgia
|
5.9%
1/17 • 3 years
|
|
Nervous system disorders
Headache
|
23.5%
4/17 • 3 years
|
|
Nervous system disorders
Hyperaesthesia
|
5.9%
1/17 • 3 years
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
1/17 • 3 years
|
|
Nervous system disorders
Intracranial aneurysm
|
11.8%
2/17 • 3 years
|
|
Nervous system disorders
Migraine
|
5.9%
1/17 • 3 years
|
|
Nervous system disorders
Sciatica
|
5.9%
1/17 • 3 years
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
5.9%
1/17 • 3 years
|
|
Nervous system disorders
Arachnoid cyst
|
5.9%
1/17 • 3 years
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
5.9%
1/17 • 3 years
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • 3 years
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • 3 years
|
|
Renal and urinary disorders
Nocturia
|
11.8%
2/17 • 3 years
|
|
Renal and urinary disorders
Pollakiuria
|
11.8%
2/17 • 3 years
|
|
Renal and urinary disorders
Polyuria
|
5.9%
1/17 • 3 years
|
|
Renal and urinary disorders
Renal impairment
|
5.9%
1/17 • 3 years
|
|
Reproductive system and breast disorders
Breast cyst
|
5.9%
1/17 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.9%
1/17 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.9%
1/17 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.9%
1/17 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
11.8%
2/17 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
1/17 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.8%
2/17 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
5.9%
1/17 • 3 years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
11.8%
2/17 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
5.9%
1/17 • 3 years
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
5.9%
1/17 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.8%
2/17 • 3 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.9%
1/17 • 3 years
|
|
Vascular disorders
Hypertension
|
29.4%
5/17 • 3 years
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place