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CLR325 for Chronic Heart Failure

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of clr325 infusion on day 1

Summary

This trial tested the safety and tolerability of a drug called CLR325, which is given directly into the bloodstream. The study focused on patients with stable heart failure to see if the drug could be safely used in this group. The goal was to determine if further research on CLR325 for heart failure is needed.

Eligible Conditions

Chronic Heart Failure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of clr325 infusion on day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of clr325 infusion on day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of clr325 infusion on day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Patients With Adverse Events, Serious Adverse Events and Death

Secondary study objectives

Number of Patients With Increase in Anti-CLR325 and Anti-apelin Antibodies in Serum

Pharmacokinetic of CLR325 and CQJ295: Amount of Drug (or Defined Metabolite) Excreted Into the Urine From Time (Ae 0-28 Hours)

Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From From Time Zero to 28 Hours (AUC0-28hrs)

+9 more

Side effects data

From 2019 Phase 2 trial • 26 Patients • NCT02696967

25%

Nausea

25%

Infusion site pruritus

25%

Headache

100%

80%

60%

40%

20%

Study treatment Arm

CLR325 0.25 mcg/kg/Min

CLR325 2.5 mcg/kg/Min

CLR325 8 mcg/kg/Min

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CLR325Experimental Treatment1 Intervention

Patients were assigned to one of the 2 treatment arms in fixed randomization ratio. Patients randomized to this arm received single dose of CLR325 (i.v.) in double blind manner.

Group II: PlaceboPlacebo Group1 Intervention

Patients were assigned to one of the 2 treatment arms in fixed randomization ratio. Patients randomized to this arm received single dose of placebo (i.v.) in double blind manner.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CLR325

2016

Completed Phase 2

~30

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