Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sorbent Therapeutics

ClinicalTrials.gov Identifier:

NCT01598740

First received: May 11, 2012

Last updated: March 22, 2013

Last verified: March 2013

History of Changes

Results First Received: March 22, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Heart Failure
Intervention:	Drug: CLP

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first subject was enrolled on 01 June 2012 and the last subject completed on 06 August 2012. The study was completed at one research center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Each study period included a 5-day baseline period followed by a 7-day treatment period. The study periods were separated by a 7-day washout period.

Reporting Groups

	Description
CLP + Spiro/CLP	Subjects in this group received coadministration of CLP and spironolactone in Period 1/administration of CLP alone in Period 2.
CLP/CLP + Spiro	Subjects in this group received administration of CLP alone in Period 1/coadministration of CLP and spironolactone in Period 2.

Participant Flow: Overall Study

	CLP + Spiro/CLP	CLP/CLP + Spiro
STARTED	9	9
COMPLETED	7	9
NOT COMPLETED	2	0

Baseline Characteristics

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Reporting Groups

	Description
CLP + Spiro/CLP	Subjects in this group received coadministration of CLP and spironolactone in Period 1/administration of CLP alone in Period 2.
CLP/CLP + Spiro	Subjects in this group received administration of CLP alone in Period 1/coadministration of CLP and spironolactone in Period 2.
Total	Total of all reporting groups

Baseline Measures

	CLP + Spiro/CLP	CLP/CLP + Spiro	Total
Number of Participants [units: participants]	9	9	18
Age, Customized [units: years] Mean ± Standard Deviation
Age (years)	56.3 ± 7.58	63.4 ± 9.77	59.9 ± 8.7
Gender [units: participants]
Female	4	1	5
Male	5	8	13
Weight [units: kg] Mean ± Standard Deviation	91.35 ± 24.20	99.54 ± 27.49	95.4 ± 25.8
Diet [units: participants]
Low sodium	1	2	3
Medium sodium	1	1	2
High sodium	7	6	13

Outcome Measures

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1. Primary:

Change in Fecal Sodium Content [ Time Frame: baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32) ]

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2. Secondary:

Change in Fecal Weight [ Time Frame: baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Howard Dittrich, MD
Organization: Sorbent Therapeutics, Inc.
phone: 858-405-1429
e-mail: hdittrich@sorbent.com

No publications provided

Responsible Party:	Sorbent Therapeutics
ClinicalTrials.gov Identifier:	NCT01598740 History of Changes
Other Study ID Numbers:	CTST-25
Study First Received:	May 11, 2012
Results First Received:	March 22, 2013
Last Updated:	March 22, 2013
Health Authority:	United States: Food and Drug Administration

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