EUCTR2010-019025-33-NL
Active, not recruiting
Not Applicable
A Phase IIa, Single-Center Study, Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/Pharmacodynamics of Oral Tolvaptan (OPC-41061) in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal Function
Otsuka Pharmaceutical Development Commercialization, Inc.0 sites36 target enrollmentJuly 27, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- Sponsor
- Otsuka Pharmaceutical Development Commercialization, Inc.
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Males and females between 18 and 70 years of age, inclusive
- •2\) Diaganosis of ADPKD by Ravine criteria:
- •With family history: several cysts per kidney (3 if by sonography, 5 if by CT or MRI)
- •Without family history: 10 cysts (by an radiologic method) per kidney and exclusion of other cystic kidney diseases
- •3\) eGFR as assessed by the MDRD equation based on an average of 2 measurements (one may be historical within 3 months prior to enrollment) that falls into one of the following strata:
- •Group A must have an eGFR of \> 60 mL/min \* 1\.73 m2
- •Group B must have an eGFR of 30\-60 ml/min \* 1\.73 m2
- •Group C must have an eGFR of \< 30 ml/min \* 1\.73m2
- •4\) Must have a negative serum pregnancy test prior to the first dose for all women of child\-bearing potential (WOCBP)
- •5\) Must have a body mass index (BMI) between 19\-32 kg/m2
Exclusion Criteria
- •1\.Men or women who will not adhere to the reproductive precautions as outlined in the informed consent form.
- •2\.Subject who is pregnant or breast\-feeding.
- •3\.Inability to take oral medications.
- •4\.Subjects who have clinically significant allergic reactions to tolvaptan or chemically related structures such as benzazepines (benzazepril, conivaptan, fenoldopam mesylate or mirtazapine)
- •5\.Subjects with a history of substance abuse (within the last 3 years).
- •6\.Subjects taking other experimental (ie, nonmarketed) therapies or current participation in another clinical drug or device trial within 30 days prior to dosing.
- •Efficacy Endpoint Specific Exclusion
- •7\.Subjects on any form of renal replacement therapy (e.g. dialysis, renal transplantation)
- •8\.Subjects taking approved therapies for the purpose of affecting PKD cysts, including but not limited to, anti\-sense RNA therapies, rapamycin, sirolimus, everolimus, or somatostatin analogs ( ie, octreotide, sandostatin).
- •9\.Prior use of a vasopressin antagonist for greater than 10 days or within 6 months of randomization.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
A Phase 2a, Single-Center Study Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/ Pharmacodynamics of Oral Tolvaptan in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal FunctioNL-OMON34527Covance36
Active, not recruiting
Phase 1
Hypoxia PET/CT Scanning in Patients with Cancer, Who are Receiving Radiotherapy (OXYPET Study)EUCTR2013-003563-58-GBottingham University Hospitals NHS Trust3
Active, not recruiting
Phase 1
A phase 2 trial for patients with locally advanced or metastatic bile duct cancer investigating treatment with cisplatin and gemcitabine with or without tocilizumab.First-line treatment in patients with locally advanced or metastatic biliary tract cancer, inoperable due to extension of the disease.MedDRA version: 25.1Level: LLTClassification code 10008594Term: Cholangiocarcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10008596Term: Cholangiocarcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10074878Term: Hilar cholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10074879Term: Extrahepatic cholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10077846Term: Cholangiocarcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2018-004826-27-DKDepartment of Oncology, Herlev & Gentofte Hospital166
Active, not recruiting
Phase 1
Phase IIa Study of avelumab and cetuximab plus gemcitabine and cisplatin in participants with squamous NSCLCon Small Cell Lung CancerMedDRA version: 21.1Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2018-001529-24-HUMerck KGaA40
Active, not recruiting
Phase 1
Phase IIa Study of avelumab and cetuximab plus gemcitabine and cisplatin in participants with squamous NSCLCon Small Cell Lung CancerMedDRA version: 20.0Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2018-001529-24-ESMerck KGaA43