Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06047171
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2023-09-05
Brief Title:
Rescue of Nephrons With ALEF02 RENAL-F02
Sponsor:
Alentis Therapeutics AG
Organization:
Alentis Therapeutics AG
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study of Intravenously Administered ALEF02 to Evaluate the Safety Tolerability Pharmacokinetics and Renal Sparing in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis With Rapidly Progressive Glomerulonephritis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RENAL-F02
Brief Summary:
The goal of this clinical trial is to learn if a new drug that might help protect and preserve kidney function in antineutrophil cytoplasmic antibody ANCA associated vasculitis AAV AAV is a type of autoimmune disease where the bodys own immune system attacks itself and in the case of AAV the body attacks its own small blood vessels There are many small blood vessels in the kidneys meaning the kidneys are commonly affected in AAV
The main questions it aims to answer are
Is the new drug well tolerated and safe
Can the new drug protect and preserve kidney functions when is added to standard therapy
Researchers will compare the following groups to see how the new drug is tolerated and what effect to preserve kidney tissue has
Group A Standard treatment ALEF02 low dose infusions
Group B Standard treatment ALEF02 high dose infusions
Group C Standard treatment ALEF02 maximum dose infusions
Group D Standard treatment placebo infusions inactive substance
The Treatment period will consist of 24 weeks beginning on Day 1 during which time participants will receive 13 infusions of the study medicine along with standard therapy for kidney inflammation due to AAV During the treatment period participants will have the following assessments
A brief physical examination focusing on their skin any pre-existing medical conditions that you have
Collection of blood and urine samples for routine safety tests and to assess renal function
Collection of blood samples
To measure the amount of study medicine in their blood This is called pharmacokinetics PK and it is tested to see how study medicine enters moves through and exits the body
To test for antidrug antibodies ADA To check if their body create antibodies against the study medicine as this could reduce its effect
To measure biomarkers Biomarkers are specific compounds in the body can be protein hormones or genetic molecules that indicate normal or abnormal processes taking place in your body and may be a sign of an underlying condition or disease for example glucose levels are used as biomarker in managing diabetes They are used to see how well the body responds to a treatment for a disease or condition
Collection of urine to measure urine markers of vasculitisinflammation called biomarkers
Urine pregnancy test A urine pregnancy test is a quick medical test that can tell if a woman is pregnant or not by checking for a hormone which is produced during pregnancy usually in the urine
Chest High Resolution Computed Tomography HRCT scan to check whether they have vasculitis affecting their lungs A CT scan uses special x-ray equipment to take detailed pictures of body tissues and organs to diagnose and monitor conditions in various parts of the body For the CT scan they will need to lie still on a table At Week 24 a second lung CT scan will be performed for participants whose initial scan showed lung vasculitis to see whether your lung vasculitis is getting better or ongoingworse
The main questions it aims to answer are
Is the new drug well tolerated and safe
Can the new drug protect and preserve kidney functions when is added to standard therapy
Researchers will compare the following groups to see how the new drug is tolerated and what effect to preserve kidney tissue has
Group A Standard treatment ALEF02 low dose infusions
Group B Standard treatment ALEF02 high dose infusions
Group C Standard treatment ALEF02 maximum dose infusions
Group D Standard treatment placebo infusions inactive substance
The Treatment period will consist of 24 weeks beginning on Day 1 during which time participants will receive 13 infusions of the study medicine along with standard therapy for kidney inflammation due to AAV During the treatment period participants will have the following assessments
A brief physical examination focusing on their skin any pre-existing medical conditions that you have
Collection of blood and urine samples for routine safety tests and to assess renal function
Collection of blood samples
To measure the amount of study medicine in their blood This is called pharmacokinetics PK and it is tested to see how study medicine enters moves through and exits the body
To test for antidrug antibodies ADA To check if their body create antibodies against the study medicine as this could reduce its effect
To measure biomarkers Biomarkers are specific compounds in the body can be protein hormones or genetic molecules that indicate normal or abnormal processes taking place in your body and may be a sign of an underlying condition or disease for example glucose levels are used as biomarker in managing diabetes They are used to see how well the body responds to a treatment for a disease or condition
Collection of urine to measure urine markers of vasculitisinflammation called biomarkers
Urine pregnancy test A urine pregnancy test is a quick medical test that can tell if a woman is pregnant or not by checking for a hormone which is produced during pregnancy usually in the urine
Chest High Resolution Computed Tomography HRCT scan to check whether they have vasculitis affecting their lungs A CT scan uses special x-ray equipment to take detailed pictures of body tissues and organs to diagnose and monitor conditions in various parts of the body For the CT scan they will need to lie still on a table At Week 24 a second lung CT scan will be performed for participants whose initial scan showed lung vasculitis to see whether your lung vasculitis is getting better or ongoingworse
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1286-9095 | OTHER | WHO universal trial number UTN | None |
| 2022-502184-38 | OTHER | None | None |