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Kidney TransplantationTICTIKNCT06488651

Trajectory of Immunosuppression-Caused Tremor In Kidney and Lung Transplant Recipients

An observational study of Kidney Transplantation and Tremor, run by University Medical Center Groningen at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Kidney and lung transplant recipients have to adhere to a strict immunosuppressive maintenance regime, generally consisting of calcineurin inhibitors (CNI). Tremor is a common and distressing side effect of CNI-use. To what extent objective and/or subjective tremor changes over time in currently unknown. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Kidney Transplantation, Tremor
How many people
72 participants
Where
1 siteNetherlands
Study dates
17 Aug 2022to 12 Sep 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: hospitalized (future) kidney and lung transplant recipients

Who may be able to join

  • Patients ≥ 16 years old, who will receive a kidney transplant or have recieved a kidney or lung transplant

Who cannot join

  • patients who are unable to comprehend the questionnaires and tests

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Groningen

    Groningen, Provincie Groningen, 9713GZ

Other trials in Netherlands

About this study

Kidney and lung transplant recipients have to adhere to a strict immunosuppressive maintenance regime, generally consisting of calcineurin inhibitors (CNI). Tremor is a common and distressing side effect of CNI-use. To what extent objective and/or subjective tremor changes over time in currently unknown. Therefore, this longitudinal prospective study aimed to assess the course of tremor in the first year after transplantation.

Read the detailed description

Kidney and lung transplant recipients 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 kidney transplant recipients who use CNIs. Higher tacrolimus blood concentration has been associated with more severe tremor, and lung transplant recipients have the highest target trough concentration. Thus, tremor may be especially an import symptom for this patient population. To what extent tremor changes over time and whether this change is objective and/or 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. We therefore aim to assess the course of tremor in the first year after kidney- and lung transplantation. We expect tremor to become less severe over time after transplantation, because patients CNI dosage decrease 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.

Keywords
Kidney transplant recipient, Tremor, Calcineurin inhibitor, Tacrolimus, Cyclosporine
Medical subject headings
Tremor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bain spirographs

    Objective measurement of tremor severity. Spirographs will be assessed blindly by two neurologists, resulting in a score ranging from 0 (best outcome) to 10 (worst outcome) on each spiral.

    Measured: From enrollment, before transplantation, to one year after transplantation

Secondary outcomes (4)

  1. The visual analog scale (VAS)

    A scale from 0 (no tremor) to 100 (most severe tremor)

    Measured: From enrollment, before transplantation, to one year after transplantation

  2. Accelerometery

    Patients with evident tremor will be invited to briefly (1 minute) wear an wrist accelerometer hourly for one day (9:00-21:00). This accelerometer, which is similar to a watch, allows us to assess tremor variability during the day.

    Measured: Measurement will be performed for the duration of one day, at a non-specific time-point after transplantation.

  3. The Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) part B

    The TRS-B relates to action tremors of the upper extremities, particulary writing and pouring liquids. Severity is determined by watching the patient carry out the aforementioned activities, after wich a score is derived that ranges from 0 points (no tremor) to 36 points (most severe tremor).

    Measured: From enrollment, before transplantation, to one year after transplantation

  4. The Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) part C

    The TRS-C consists of eight questions to assess patient-perceived tremor occurrence during ADL, including writing, speaking, and bringing food or liquids to the mouth. To every question, patients graded the impairment tremor has on ADL with a score ranging from 0 (no influence of tremor on ADL) to 4 (severe influence of tremor on ADL). A total score was calculated by summing the individual scores, with a theoretical minimum score of 0 (no tremor) and a maximum score of 32 points (most severe tremor).

    Measured: From enrollment, before transplantation, to one year after transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study start17 Aug 2022
  3. Primary completion12 Sep 2025
  4. Study completion12 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06488651
Sponsor's protocol ID
METc 2022/392
Other IDs
11036
Acronym
TICTIK
Status last verified
Dec 2024
First submitted
11 Jun 2024
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. FK506 Kidney Transplant Study Group. Transplantation. 1997 Apr 15;63(7):977-83. doi: 10.1097/00007890-199704150-00013.

    PubMed 9112351

  • David-Neto E, Lemos FBC, Arai Furusawa E, Schwartzman BS, Cavalcante JS, Yagyu EM, Romano P, Ianhez LE. Impact of cyclosporin A pharmacokinetics on the presence of side effects in pediatric renal transplantation. J Am Soc Nephrol. 2000 Feb;11(2):343-349. doi: 10.1681/ASN.V112343.

    PubMed 10665942

  • Erro R, Bacchin R, Magrinelli F, Tomei P, Geroin C, Squintani G, Lupo A, Zaza G, Tinazzi M. Tremor induced by Calcineurin inhibitor immunosuppression: a single-centre observational study in kidney transplanted patients. J Neurol. 2018 Jul;265(7):1676-1683. doi: 10.1007/s00415-018-8904-x. Epub 2018 May 18.

    PubMed 29777361

  • Paul F, Muller J, Christe W, Steinmuller T, Poewe W, Wissel J. Postural hand tremor before and following liver transplantation and immunosuppression with cyclosporine or tacrolimus in patients without clinical signs of hepatic encephalopathy. Clin Transplant. 2004 Aug;18(4):429-33. doi: 10.1111/j.1399-0012.2004.00184.x.

    PubMed 15233821

  • Morgan JC, Kurek JA, Davis JL, Sethi KD. Insights into Pathophysiology from Medication-induced Tremor. Tremor Other Hyperkinet Mov (N Y). 2017 Nov 22;7:442. doi: 10.7916/D8FJ2V9Q. eCollection 2017.

    PubMed 29204312

  • Bhatia KP, Bain P, Bajaj N, Elble RJ, Hallett M, Louis ED, Raethjen J, Stamelou M, Testa CM, Deuschl G; Tremor Task Force of the International Parkinson and Movement Disorder Society. Consensus Statement on the classification of tremors. from the task force on tremor of the International Parkinson and Movement Disorder Society. Mov Disord. 2018 Jan;33(1):75-87. doi: 10.1002/mds.27121. Epub 2017 Nov 30.

    PubMed 29193359

  • Naesens M, Kuypers DR, Sarwal M. Calcineurin inhibitor nephrotoxicity. Clin J Am Soc Nephrol. 2009 Feb;4(2):481-508. doi: 10.2215/CJN.04800908.

    PubMed 19218475

  • Kugler C, Fischer S, Gottlieb J, Tegtbur U, Welte T, Goerler H, Simon A, Haverich A, Strueber M. Symptom experience after lung transplantation: impact on quality of life and adherence. Clin Transplant. 2007 Sep-Oct;21(5):590-6. doi: 10.1111/j.1399-0012.2007.00693.x.

    PubMed 17845632

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplantation and Tremor, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bain spirographs (time frame: From enrollment, before transplantation, to one year after transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06488651, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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