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International, Multicenter, Open-Label and Randomized Withdrawal Study of Oral Lixivaptan in Heart Failure Patients With Chronic Hyponatremia

Primary Purpose

Hypervolemic Hyponatremia

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Lixivaptan

About this trial

This is an interventional treatment trial for Hypervolemic Hyponatremia focused on measuring hypervolemic hyponatremia, serum sodium, fluid overload, heartfailure, acute heart failure, vasopressin antagonist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and Women with age greater than or equal to 18 years.
Prior successful participation in a randomized, blinded, placebo-controlled Phase 3 lixivaptan study of hyponatremia in Heart Failure (Protocol CK-LX3401) with evidence of continued need for therapy as follows:
- Patient completed full course of treatment (e.g., either placebo or lixivaptan). Treatment assignments for Protocol CK-LX3401 will not be unblinded prior to participation in the extension study.
- Baseline serum sodium concentration < 135 mEq/L following a 30 day post treatment follow-up period in a lixivaptan hyponatremia parent trial. Repeat measures of serum sodium are allowed; the last serum sodium result within 24 hours prior to randomization will serve as the qualifying measurement.
The patient has clinical evidence of volume overload with at least one of the following:
- Dyspnea
- Pulmonary congestion (rales)
- Peripheral edema
- Increased jugular venous pressure and/or hepatic congestion with ascites
- Chest x-ray consistent with CHF; OR
- Plasma BNP ≥150 pg/mL or NT pro-BNP ≥ 450 pg/mL

Exclusion Criteria:

Women who are pregnant (positive pregnancy test), breastfeeding or who will not adhere to the reproductive precautions as outlined in this protocol and in the informed consent form.
Inability to provide informed consent.
Acute severe hyponatremia with overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures).
Acute or transient hyponatremia (e.g., associated with head trauma or postoperative state).
Hyponatremia in hypovolemic states. Hypovolemia is defined as the presence of clinical evidence of fluid volume depletion.
Euvolemic Hyponatremia (e.g., SIADH, etc.). Euvolemic hyponatremia is defined as low serum sodium in the presence of normal total body sodium due to mild to moderate increases in total body water without edema.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo QD or BID

Lixivaptan QD or BID

Arm Description

Placebo QD or BID

Lixivaptan QD or BID

Outcomes

Primary Outcome Measures

To demonstrate that after 12 weeks of open-label lixivaptan treatment, serum sodium is maintained in hyponatremic patients continuing to receive lixivaptan compared to placebo during the 4 week double blind treatment period.

Secondary Outcome Measures

To demonstrate that after 12 weeks of open-label lixivaptan treatment, improvements in the time to complete the Trail Making Test (Part B) will be maintained in patients continuing to receive lixivaptan.

Full Information

NCT ID

NCT00876876

First Posted

April 3, 2009

Last Updated

November 19, 2010

Sponsor

CardioKine Inc.

Collaborators

Cardiokine Biopharma, LLC, Biogen

1. Study Identification

Unique Protocol Identification Number

NCT00876876

Brief Title

International, Multicenter, Open-Label and Randomized Withdrawal Study of Oral Lixivaptan in Heart Failure Patients With Chronic Hyponatremia

Official Title

International, Multicenter, Open-Label and Randomized Withdrawal Study of Oral Lixivaptan in Heart Failure Patients With Chronic Hyponatremia

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Withdrawn

Why Stopped

Created Extension study - This study was no longer feasible

Study Start Date

July 2009 (undefined)

Primary Completion Date

August 2010 (Anticipated)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

CardioKine Inc.

Collaborators

Cardiokine Biopharma, LLC, Biogen

4. Oversight

5. Study Description

Brief Summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypervolemic Hyponatremia

Keywords

hypervolemic hyponatremia, serum sodium, fluid overload, heartfailure, acute heart failure, vasopressin antagonist

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo QD or BID

Arm Type

Placebo Comparator

Arm Description

Placebo QD or BID

Arm Title

Lixivaptan QD or BID

Arm Type

Experimental

Arm Description

Lixivaptan QD or BID

Intervention Type

Drug

Intervention Name(s)

Lixivaptan

Intervention Description

Capsules containing 25, or 50 mg doses of oral lixivaptan to be administered BID or QD Lixivaptan will be administered for 12 weeks in the Open-Label Period which will be followed by a 4 week Randomized, Placebo-Controlled period.

Primary Outcome Measure Information:

Title

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Time Frame

20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and Women with age greater than or equal to 18 years. Prior successful participation in a randomized, blinded, placebo-controlled Phase 3 lixivaptan study of hyponatremia in Heart Failure (Protocol CK-LX3401) with evidence of continued need for therapy as follows: Patient completed full course of treatment (e.g., either placebo or lixivaptan). Treatment assignments for Protocol CK-LX3401 will not be unblinded prior to participation in the extension study. Baseline serum sodium concentration < 135 mEq/L following a 30 day post treatment follow-up period in a lixivaptan hyponatremia parent trial. Repeat measures of serum sodium are allowed; the last serum sodium result within 24 hours prior to randomization will serve as the qualifying measurement. The patient has clinical evidence of volume overload with at least one of the following: Dyspnea Pulmonary congestion (rales) Peripheral edema Increased jugular venous pressure and/or hepatic congestion with ascites Chest x-ray consistent with CHF; OR Plasma BNP ≥150 pg/mL or NT pro-BNP ≥ 450 pg/mL Exclusion Criteria: Women who are pregnant (positive pregnancy test), breastfeeding or who will not adhere to the reproductive precautions as outlined in this protocol and in the informed consent form. Inability to provide informed consent. Acute severe hyponatremia with overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures). Acute or transient hyponatremia (e.g., associated with head trauma or postoperative state). Hyponatremia in hypovolemic states. Hypovolemia is defined as the presence of clinical evidence of fluid volume depletion. Euvolemic Hyponatremia (e.g., SIADH, etc.). Euvolemic hyponatremia is defined as low serum sodium in the presence of normal total body sodium due to mild to moderate increases in total body water without edema.

12. IPD Sharing Statement

Learn more about this trial

International, Multicenter, Open-Label and Randomized Withdrawal Study of Oral Lixivaptan in Heart Failure Patients With Chronic Hyponatremia

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