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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06598631




Registration number
NCT06598631
Ethics application status
Date submitted
12/09/2024
Date registered
19/09/2024

Titles & IDs
Public title
Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease
Scientific title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease
Secondary ID [1] 0 0
J3E-MC-EZDC
Secondary ID [2] 0 0
18839
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Volenrelaxin
Treatment: Drugs - Placebo

Experimental: Volenrelaxin Dose 1 - Participants will receive Volenrelaxin subcutaneously (SC)

Experimental: Volenrelaxin Dose 2 - Participants will receive Volenrelaxin SC

Experimental: Volenrelaxin Dose 3 - Participants will receive Volenrelaxin SC

Placebo comparator: Placebo - Participants will receive Placebo SC


Treatment: Drugs: Volenrelaxin
Administered SC

Treatment: Drugs: Placebo
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change from Baseline of Urine Albumin-Creatinine Ratio (UACR)
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Change from Baseline in eGFR
Timepoint [2] 0 0
Baseline, Week 12

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Louisiana
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
China
State/province [6] 0 0
Shandong
Country [7] 0 0
China
State/province [7] 0 0
Zhejiang
Country [8] 0 0
Japan
State/province [8] 0 0
Kanagawa
Country [9] 0 0
Japan
State/province [9] 0 0
Okayama
Country [10] 0 0
Spain
State/province [10] 0 0
A Coruña [La Coruña]
Country [11] 0 0
Spain
State/province [11] 0 0
Andalucía
Country [12] 0 0
Spain
State/province [12] 0 0
Barcelona [Barcelona]
Country [13] 0 0
Spain
State/province [13] 0 0
Madrid, Comunidad De
Country [14] 0 0
Spain
State/province [14] 0 0
Valenciana, Comunitat

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
ClinicalTrials.gov@lilly.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06598631