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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01214421
First Posted: October 5, 2010
Last Update Posted: March 27, 2017
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.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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 ]
    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


Enrollment: 1083
Study Start Date: May 2010
Study Completion Date: March 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 251 Prior Tolvaptan 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 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 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( EudraCT Number )
First Submitted: September 26, 2010
First Posted: October 5, 2010
Last Update Posted: March 27, 2017
Last Verified: March 2017

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
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs