Clinical trial NCT06598631: Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Keywords: eGFR
UACR
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to investigate the efficacy and safety of Volenrelaxin in adults with Chronic Kidney Disease. The study will last about 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of Chronic Kidney Disease (CKD) based on eGFR category and albuminuria category per the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
* Have been on a maximally tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for 90 days preceding screening and is expected to remain on a stable regimen through the study
* If on additional treatment for CKD, must be on stable dose for at least 90 days before screening.
* If diagnosed with Type 2 Diabetes, should be on stable antihyperglycemic treatment for at least 90 days before screening.

Exclusion Criteria:

* Have any one of the following cardiovascular conditions 90 days prior to screening:

  * myocardial infarction
  * stroke
  * hospitalization or urgent visit for heart failure, and
  * coronary, carotid, or peripheral artery revascularization.
* Have a documented New York Heart Association (NYHA) Class IV heart failure at the time of screening.
* Have chronic or intermittent hemodialysis or peritoneal dialysis 90 days prior to screening.
* Have acute dialysis or acute kidney injury 90 days prior to screening.
* Have a history of a congenital or hereditary kidney disease, polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, and nephrotic syndrome
* Requires chronic immunosuppression.
* Have HbA1c \>8.5% at screening
* Have had a transplanted organ or are awaiting an organ transplant
* Have a diagnosis or history of malignant disease within 5 years prior to baseline.
* Have symptomatic hypotension.
* Have acute or chronic hepatitis.

Primary outcomes:
measure: Percent Change from Baseline of Urine Albumin-Creatinine Ratio (UACR)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline, Week 12
measure: Change from Baseline in eGFR
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Research Institute
state: California
city: Evergreen Park
country: United States
facility: Southwest Nephrology Associates
state: Illinois
city: Hinsdale
country: United States
facility: Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale
state: Illinois
city: Huntley
country: United States
facility: Nephrology Associates of Northern Illinois and Indiana (NANI) - Huntley
state: Illinois
city: Fort Wayne
country: United States
facility: Nephrology Associates of Northern Illinois and Indiana (NANI) - Fort Wayne
state: Indiana
city: Indianapolis
country: United States
facility: Nephrology Associates of Northern Illinois and Indiana - IKS - Indianapolis South
state: Indiana
city: Metairie
country: United States
facility: Diabetes and Metabolism Associates, APMC
state: Louisiana
city: Flint
country: United States
facility: Elite Clinical Research Center
state: Michigan
city: Greenville
country: United States
facility: Eastern Nephrology Associates - Greenville
state: North Carolina
city: Jacksonville
country: United States
facility: Eastern Nephrology Associates
state: North Carolina
city: Kinston
country: United States
facility: Eastern Nephrology Associates- Kinston Office
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: New Bern
country: United States
facility: Eastern Nephrology Associates- New Bern Office
state: North Carolina
city: Wilmington
country: United States
facility: Eastern Nephrology Associates - Wilmington
state: North Carolina
city: Houston
country: United States
facility: Endocrine Associates
state: Texas
city: Odessa
country: United States
facility: Permian Research Foundation
state: Texas
city: Gosford
country: Australia
facility: Renal Research - Gosford
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Taian
country: China
facility: Taian City Central Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Ningbo
country: China
facility: Ningbo 2nd Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The first affiliated hospital of Ningbo university
state: Zhejiang
city: Kamakura-shi
country: Japan
facility: Takai Internal Medicine Clinic
state: Kanagawa
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: A Coruña
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña
state: A Coruña [La Coruña]
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Andalucía
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Lugo
country: Spain
facility: Hospital Ribera Polusa
state: Lugo [Lugo]
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia
state: Valenciana, Comunitat
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: