8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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Brief Title

8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Official Title

A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Placebo-masked, Parallel-group Pilot Trial to Compare the Efficacy, Tolerability, and Safety of Tolvaptan Modified-release and Immediate-release Formulations in Subjects With Autosomal Dominant Polycystic Kidney Disease

Brief Summary

      The purpose of this study is to compare the short-term effects of two tolvaptan formulations
      in patients with ADPKD.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percent Change From Baseline in Total Kidney Volume (TKV) at Week 3

Secondary Outcome

 Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)

Condition

Autosomal Dominant Polycystic Kidney Disease

Intervention

Tolvaptan MR

Study Arms / Comparison Groups

 Tolvaptan MR 50 mg
Description:  Tolvaptan MR 50 mg capsule and 2 placebo IR tablets ( 8 AM) and 1 placebo IR tablet (4 PM) daily.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

178

Start Date

October 2011

Completion Date

July 2013

Primary Completion Date

July 2013

Eligibility Criteria

        Inclusion Criteria:

          1. Age 18 to 50

          2. Subjects with:

               -  BMI between 19 and 35 kg/m2

               -  diagnosis of ADPKD by modified Ravine criteria:

                    -  family history: 3cysts/kidney if by sonography or 5 by CT or MRI

                    -  Without family history: 10 cysts per kidney

               -  an eGFR > 45 mL/min/1.73 m2 by the CKD-EPI equation

          3. Subjects not planning to become pregnant willing to comply with birth control
             requirements.

          4. Subjects must be in good health as determined by screening tests.

          5. Subjects providing informed consent and able to comply with all trial requirements.

        Exclusion Criteria:

          1. Subjects using diuretics within 14 days prior to randomization, or the requirement for
             intermittent or constant diuretic use for any reason

          2. Subjects who had an eGFR < 45 mL/min/1.73 m2 calculated based on the most recent
             historical creatinine during the last 12 months

          3. Subjects with:

               -  incontinence, overactive bladder, or urinary retention (eg, BPH), meaning
                  subjects with symptoms of frequent nocturia, as determined by medical history or
                  urinary urgency should be carefully evaluated to exclude non-ADPKD GU issues
                  prior to entry.

               -  liver disease, liver function abnormalities, or serology other than that expected
                  for ADPKD with cystic liver disease at baseline

               -  a history of renal surgery or cyst drainage within 6 months of randomization

               -  blood pressure 150/95 mmHg or < 90/40 mmHg.

               -  heart rate outside the range of 40 to 90 bpm.

               -  advanced diabetes with a history of poor control, evidence of significant renal
                  disease renal cancer, single kidney, or recent renal surgery

               -  other significant medical history that may interfere with the study objectives

               -  significant abnormalities in serum sodium concentration (< 135 or > 145 mEq/L)

               -  a history of drug and/or alcohol abuse within 2 years prior to screening

               -  clinically significant allergic reactions to tolvaptan or chemically related
                  structures such as benzazepines (eg, benzazepril, conivaptan, fenoldopam
                  mesylate, or mirtazapine)

          4. Subjects having taken an investigational drug within 30 days preceding randomization
             on Day 0

          5. Subjects taking medications or having concomitant illnesses likely to confound
             endpoint assessments, including taking approved (ie, marketed) therapies for the
             purpose of affecting PKD cysts such as tolvaptan, somatostatin agonists (ie,
             octreotide, sandostatin), Rapamune (sirolimus), anti-sense RNA therapies, other
             vasopressin antagonists (eg, OPC-31260 [mozavaptan] and Vaprisol® [conivaptan]) or
             agonists (eg, desmopressin), and cyst reduction surgery

          6. Subjects on antihypertensives that have not been on the same antihypertensive regimen
             for at least 30 days prior to the first dose of IMP

          7. Subjects having contraindications to, or interference with, MRI assessments

          8. Subjects with a history of serious mental disorders that, in the opinion of the
             investigator, would exclude the subject from participating in this trial

          9. Subjects with previous exposure to tolvaptan
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Frank Czerwiec, M.D., Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01451827

Organization ID

156-09-290


Responsible Party

Sponsor

Study Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.


Study Sponsor

Frank Czerwiec, M.D., Ph.D., Study Director, Otsuka Pharmaceutical Development & Commercialization, Inc.


Verification Date

August 2018