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Polyelectrolyte

CLP for Heart Failure (STEPWISE Trial)

Phase 2
Waitlist Available
Research Sponsored by Sorbent Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21 years or older at randomization
Peripheral (or sacral) edema >1+ or ascites during screening or on day of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

STEPWISE Trial Summary

This is a placebo-controlled study to determine the effect of CLP in heart failure subjects with fluid overload.

STEPWISE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

STEPWISE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite endpoint comprised of: 6-Minute Walk Test, Body weight, KCCQ Score, Log2 NT-proBNP, time to first occurrence of heart/renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart/renal failure or death
Secondary outcome measures
Change in 6-Minute Walk Test distance from baseline to Week 8.
Time to heart failure or renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart failure or renal failure, or death

Side effects data

From undefined Phase 2 trial • 113 Patients • NCT01265524
12%
Abdominal discomfort
7%
Oedema peripheral
5%
Abdominal distention
5%
Nausea
3%
Decreased appetite
3%
Hyperkalaemia
2%
Vomiting
2%
Hypertension
2%
Cardiac failure
2%
Cardiac failure acute
2%
Sudden death
2%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Investigational Drug: CLP

STEPWISE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CLPExperimental Treatment1 Intervention
CLP BID
Group II: PlaceboPlacebo Group1 Intervention
BID powder
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CLP
2011
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Sorbent TherapeuticsLead Sponsor
4 Previous Clinical Trials
181 Total Patients Enrolled
2 Trials studying Heart Failure
131 Patients Enrolled for Heart Failure
Howard Dittrich, MDStudy ChairSorbent Therapeutics, Study Sponsor
2 Previous Clinical Trials
410 Total Patients Enrolled
1 Trials studying Heart Failure
18 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~22 spots leftby Mar 2025