Open-Label Tolvaptan Study in Subjects With ADPKD (TEMPO 4/4)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01214421
First received: September 26, 2010
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from baseline (from trial 156-04-251) in total kidney volume (TKV) and renal function.


Condition Intervention Phase
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Drug: Tolvaptan
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Percent Change in Total Kidney Volume (TKV) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    For subjects continuing from protocol 156-04-251: change from 251 baseline TKV at month 24 of 156-08-271 comparing those previously treated with tolvaptan to those previously treated with placebo


Secondary Outcome Measures:
  • Change in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    For subjects randomized to tolvaptan and placebo in 156-04-251 and enrolled and treated in 156-08-271 as early treated and delayed treatment groups: change from 251 baseline eGFR at month 24 of 156-08-271

  • Slope of Total Kidney Value (TKV) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    For subjects randomized to tolvaptan and placebo in 156-04-251 and enrolled and treated in 156-08-271 as early treated and delayed treatment groups

  • Slope of eGFR (CKD-EPI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    For subjects randomized to tolvaptan and placebo in 156-04-251 and enrolled and treated in 156-08-271 as early treated and delayed treatment groups


Estimated Enrollment: 1500
Study Start Date: May 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 251 Prior Tolvaptan
Patients enrolling from protocol 156-04-251 in the tolvaptan-treated group
Drug: Tolvaptan
Daily split-dose of tolvaptan titrated to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
Other Names:
  • OPC-41061
  • OPC-156
Experimental: 251 Prior Placebo
Patients enrolling from protocol 156-04-251 in the placebo-treated group
Drug: Tolvaptan
Daily split-dose of tolvaptan titrated to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
Other Names:
  • OPC-41061
  • OPC-156
Experimental: Other Prior Study
Patients enrolling from prior tolvaptan studies other than protocol 156-04-251
Drug: Tolvaptan
Daily split-dose of tolvaptan titrated to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
Other Names:
  • OPC-41061
  • OPC-156

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects who have successfully completed a Phase 1, 2, or 3 tolvaptan ADPKD or renal impairment trial, with a confirmed diagnosis of ADPKD

Exclusion Criteria:

  • Subjects unable to provide written informed consent
  • Subjects (men or women) who will not adhere to the reproductive precautions as outlined in the Informed Consent Form
  • Subjects (women only) with a positive urine pregnancy test
  • Subjects who are pregnant or breast-feeding
  • Subjects unable to take oral medications
  • Subjects who have allergic reactions to tolvaptan or chemically related structures such as benzazepines (benzazepril, conivaptan, fenoldopam mesylate or mirtazapine)
  • Subjects who have disorders in thirst recognition or an inability to access fluids
  • Subjects with critical electrolyte imbalances, as determined by the investigator
  • Subjects with or at risk of significant hypovolemia, as determined by investigator
  • Subjects with anemia, as determined by investigator
  • Subjects with a history of substance abuse (within the last 3 years)
  • Subjects taking other experimental (ie, non-marketed) therapies or current participation in another clinical drug or device trial; current participation in the off-drug follow-up period of another ADPKD trial with tolvaptan is permitted

Efficacy Analysis Exclusion Criteria:

  • Subjects unable to complete MRI assessments(eg, subjects with ferro-magnetic prostheses, aneurysm clips, severe claustrophobia)
  • Subjects who have taken a vasopressin antagonist (outside of previous participation in a tolvaptan trial)
  • Subjects unable to comply with anti-hypertensive or other important medical therapy
  • Subjects with advanced diabetes
  • Subjects taking medications or having an illness that could confound endpoint assessments (including taking approved therapies for the purpose of affecting PKD cysts)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214421

  Show 99 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
Study Director: Frank Czerwiec, MD, PhD Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01214421     History of Changes
Other Study ID Numbers: 156-08-271, 2010-018401-10
Study First Received: September 26, 2010
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Argentina: Ministry of Health
Australia: Human Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: National Consultative Ethics Committee for Health and Life Sciences
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Belgium: Ethics Committee
Netherlands: Independent Ethics Committee
Poland: Ethics Committee
Romania: Ethics Committee
Russia: Ethics Committee

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Kidney Disease
ADPKD
Autosomal Dominant Polycystic Kidney Disease
Adult Polycystic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic

ClinicalTrials.gov processed this record on July 20, 2014