Ignite Creation Date:
2024-07-17 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483139
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Novel Treatments in Improving Renal Outcomes in Light Chain Cast Nephropathy
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
The Effect of Novel Treatments in Improving Renal Outcomes Among Patients With Light Chain Cast Nephropathy
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
Objective 1 To test whether treatment with plasma exchange improves renal recovery in patients with light chain cast nephropathy Objective 2 To compare renal outcomes among patients treated with plasma exchange versus daratumumab-based regimens versus non-daratumumab based-regimens
Detailed Description:
Objective 1
We will collect data from patients treated with plasma exchange from major centers across the United States to investigate whether plasma exchange improves renal outcomes
Specifically we will collect data on at least 150 patients treated with plasma exchange along with 300 control patients not treated with plasma exchange
Objective 2
We will compare renal outcomes among patients with light chain cast nephropathy and AKI treated with plasma exchange n150 versus daratumumab based regimen eg Dara-CyborD n150 versus other novel regimens eg CyborD or another non-daratumumab-based regimen n150 We will examine whether patients who receive dara-based regimens are more likely to have renal recovery compared to patients who do not receive dara-based regimens and to patients who receive plasma exchange Given the infrequency with which plasma exchange is performed on a single-center level we will compare outcomes among patients treated with plasma exchange utilizing data from the multicenter study to those patients who were treated with daratumumab-based regimens without plasma exchange versus non- daratumumab-based regimen
We will collect data from patients treated with plasma exchange from major centers across the United States to investigate whether plasma exchange improves renal outcomes
Specifically we will collect data on at least 150 patients treated with plasma exchange along with 300 control patients not treated with plasma exchange
Objective 2
We will compare renal outcomes among patients with light chain cast nephropathy and AKI treated with plasma exchange n150 versus daratumumab based regimen eg Dara-CyborD n150 versus other novel regimens eg CyborD or another non-daratumumab-based regimen n150 We will examine whether patients who receive dara-based regimens are more likely to have renal recovery compared to patients who do not receive dara-based regimens and to patients who receive plasma exchange Given the infrequency with which plasma exchange is performed on a single-center level we will compare outcomes among patients treated with plasma exchange utilizing data from the multicenter study to those patients who were treated with daratumumab-based regimens without plasma exchange versus non- daratumumab-based regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None