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: October 18, 2012

Last verified: October 2012

History of Changes

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:

Genetics Home Reference related topics: polycystic kidney disease

Drug Information available for: Tolvaptan

U.S. FDA Resources

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

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

Show 110 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):

Blumenfeld JD, Tepler J, Mauer A, Coller B, Bichet DG, Smith B. Tolvaptan inhibition of desmopressin effects on coagulation factors in a patient with decreased von Willebrand factor and polycystic kidney disease. Blood. 2011 Jul 14;118(2):474-6. No abstract available.

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:	October 18, 2012
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 May 22, 2013

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