Ignite Creation Date:
2024-07-17 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488651
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-11
Brief Title:
Trajectory of Immunosuppression-Caused Tremor In Kidney Transplant Recipients
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Trajectory of Immunosuppression-Caused Tremor In Kidney Transplant Recipients
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:
TICTIK
Brief Summary:
Kidney transplant recipients KTR have to adhere to a strict immunosuppressive maintenance regime generally including calcineurin inhibitors CNIs These CNIs including cyclosporine and tacrolimus are essential to prevent graft rejection but are associated with multiple side-effects One of the most frequently reported side-effects of CNIs is the development of tremor rhythmic sinusoidal oscillations of the limbs head or trunk CNI-induced tremor generally occurs soon after initiation of CNI maintenance therapy and occurs in up to half of KTR using CNIs To what extent tremor changes over time and whether this change is objective andor subjective is currently unknown In-depth investigation of the course of tremor is therefore warranted which would add valuable information to previous studies on tremor prevalence
The investigators aim to assess the course of tremor among KTR The hypothesis is that tremor becomes less severe over time after transplantation because CNI dosage decreases with time after transplantation However it may also be hypothesized that CNI neurotoxicity may accumulate with consequent worsening of tremor More information regarding the course of tremor after transplantation is essential to increase understanding of CNI-induced tremor as well as for patient counselling and future research to alleviate the burden of CNI-induced tremor
The investigators aim to assess the course of tremor among KTR The hypothesis is that tremor becomes less severe over time after transplantation because CNI dosage decreases with time after transplantation However it may also be hypothesized that CNI neurotoxicity may accumulate with consequent worsening of tremor More information regarding the course of tremor after transplantation is essential to increase understanding of CNI-induced tremor as well as for patient counselling and future research to alleviate the burden of CNI-induced tremor
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 |
|---|---|---|---|
| 11036 | REGISTRY | None | None |