---
title: Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease
nct_id: NCT01598740
overall_status: COMPLETED
phase: PHASE1
sponsor: Sorbent Therapeutics
study_type: INTERVENTIONAL
primary_condition: Heart Failure
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01598740.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01598740"
ct_last_update_post_date: 2013-07-19
last_seen_at: "2026-05-12T06:02:37.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease

**Official Title:** A Phase 1, Open-label, Randomized, Crossover Study to Assess the Safety, Tolerability, and Efficacy of CLP With and Without Spironolactone in Adults With Heart Failure

**NCT ID:** [NCT01598740](https://clinicaltrials.gov/study/NCT01598740)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 18
- **Lead Sponsor:** Sorbent Therapeutics
- **Conditions:** Heart Failure
- **Start Date:** 2012-06
- **Completion Date:** 2012-09
- **CT.gov Last Update:** 2013-07-19

## Brief Summary

The purpose of this study is to determine the effects of CLP, with and without spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic kidney disease.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Heart failure with New York Heart Association (NYHA) Classification II or III
* Chronic kidney disease
* Cardiac ejection fraction \<40%
* On heart failure therapy including an ACEI or ARB, and a BB
* Willing to understand and comply with study procedures and provide written informed consent.

Exclusion Criteria:

* Hospitalization within 4 weeks of baseline visit
* History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures
* Current or anticipated dialysis during study
* In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological, or other disease or condition that makes the subject's study participation unsafe
* Drug or alcohol abuse
```

## Arms

- **CLP with spironolactone** (EXPERIMENTAL)
- **CLP without spironolactone** (EXPERIMENTAL)

## Interventions

- **CLP** (DRUG) — Oral administration
- **Spironolactone** (DRUG) — oral administration

## Primary Outcomes

- **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))_ — Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)

## Secondary Outcomes

- **Change in Fecal Weight** _(time frame: baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32))_

## Locations (1)

- Orange Country Research Center, Tustin, California, United States

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.orange country research center|tustin|california|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01598740.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01598740*  
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