MANP for Chronic Kidney Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Chronic Kidney Diseases+3 More
MANP - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying how two drugs affect people with different types of heart failure.

Eligible Conditions
  • Chronic Kidney Diseases
  • Chronic Kidney Disease (CKD)
  • Heart Failure With Preserved Ejection Fraction (HFpEF)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 24 hours

24 hours
Change in Composite Score of cGMP, sodium excretion, GFR, and Anx-A1 Plasma cGMP, urinary cGMP, urinary sodium excretion, GFR, ANX-A1acute VE with MANP
Body Weight Changes
Change in Plasma NT-pro BNP
Change in Plasma cGMP

Trial Safety

Safety Progress

1 of 3

Trial Design

6 Treatment Groups

HFpEF-EI with MANP and oral placebo
1 of 6
HFpEF-CKD with MANP and oral placebo
1 of 6
HFpEF-CKD with Sacbitril/Valsartan with an injected placebo
1 of 6
HFpEF-EI with Sacbitril/Valsartan with an injected placebo
1 of 6
HFpEF-EI with an oral and injected placebo
1 of 6
HFpEF-CKD with an oral and injected placebo
1 of 6

Experimental Treatment

Non-Treatment Group

60 Total Participants · 6 Treatment Groups

Primary Treatment: MANP · Has Placebo Group · Phase 1 & 2

HFpEF-EI with MANP and oral placeboExperimental Group · 2 Interventions: MANP, Oral Placebo · Intervention Types: Drug, Drug
HFpEF-CKD with MANP and oral placeboExperimental Group · 2 Interventions: MANP, Oral Placebo · Intervention Types: Drug, Drug
HFpEF-CKD with Sacbitril/Valsartan with an injected placeboExperimental Group · 2 Interventions: Sacubitril/Valsartan, Injection Placebo · Intervention Types: Drug, Drug
HFpEF-EI with Sacbitril/Valsartan with an injected placeboExperimental Group · 2 Interventions: Sacubitril/Valsartan, Injection Placebo · Intervention Types: Drug, Drug
HFpEF-EI with an oral and injected placeboPlaceboComparator Group · 2 Interventions: Injection Placebo, Oral Placebo · Intervention Types: Drug, Drug
HFpEF-CKD with an oral and injected placeboPlaceboComparator Group · 2 Interventions: Injection Placebo, Oral Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MANP
2017
Completed Phase 1
~60
Sacubitril/Valsartan
2018
Completed Phase 3
~1670
Oral Placebo
2017
Completed Phase 4
~3500

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hours

Who is running the clinical trial?

Horng ChenLead Sponsor
3 Previous Clinical Trials
107 Total Patients Enrolled
Paul M McKiePrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
60 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have increased LV filling pressures, including at least 2 of the following: average septal-lateral E/e' ratio > 15; tricuspid regurgitation (TR) peak velocity > 2:8 m/s.
You have a previous diagnosis of HF with NYHA functional class II-III symptoms on chronic loop diuretic therapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: November 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.