ClinicalTrials.gg
Not yet recruitingNCT06737094CRAMéREINUpdated Dec 17, 2024

Prevalence and Severity of Cramps in Chronic Kidney Disease Patients

An observational study in Cramps and Chronic Kidney Disease(CKD), sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-17.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study summary

Cramps are a frequent and severe complication in CKD patients. Their characteristics : triggering factors, associated factors, are not well known. There is no recognized effective treatment. Using a questionnaire, the investigators wish to determine prevalence, severity and associated factors of cramps in our CKD patients. Better knowledge about cramps in CKD patients will allow to better support, and give a practical tool for treatment evaluation.

Read the detailed description

The investigator have elaborated a specific questionnaire for our CKD patient about cramps. This questionnaire concerns only cramps, regardless of the origin. The first question of the questionnaire will allow to evaluate the prevalence of cramps in our population of CKD patients. Every patient will indicate his medical treatment and biological datas. Only patients who will answer " Yes " to the first question will complete the cramp score of gravity questionnaire. This score is composed of 4 items : frequency of crisis, there impact on sleep, there duration and there intesity Patients will also indicate for how long time there have experimented cramps, the muscular zones involved, associated symptoms, triggering factors, and does something can help them for cramps (medicinal or non medicinal).

The third part concerns there treatment and biological datas. Finally there will complete the QOL-SF12 questionnaire.

02

Conditions studied

  • Cramps
  • Chronic Kidney Disease(CKD)

Keywords

  • Cramps
  • Chronic Kidney Disease
  • Pain
03

In context

Muscle Cramp

65 studies on the registry are indexed under Muscle Cramp; 9 are open to participants now.

Browse Muscle Cramp studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Every patient with Chronic Kidney Disease (non dialysis and dialysis patients)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Voluntary patients with CKD III to V (\<60ml/mn/1,72M2), including dialysed patients (hemodialysis or peritoneal dialysis).
  • Non opposed to participate to the research.

Exclusion criteria

Exclusion Criteria:

  • Transplanted patient with functional graft.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • Chronic Kidney Disease (CKD) Patients

    Patients with CKD stade III to V (dialysis and non dialysis)

06

What researchers measure

Primary outcomes

  1. Prevalence of cramps in CKD III-V patients. Number of patients having cramps / number of questionned patients

    Time frame: Day 0 - visit of inclusion

Secondary outcomes

  1. Measure of Severity of cramps

    with a scale

    Time frame: Day 0 - visit of inclusion

  2. Frequency of pain intensity

    Time frame: Day 0 - visit of inclusion

  3. Identification of potential triggering factors

    through a questionnaire triggering factors will be identified

    Time frame: Day 0 - visit of inclusion

  4. Identification of associated factors (ionic desorders, medical treatment, degree of CKD, …)

    Time frame: Day 0 - visit of inclusion

  5. Identification of potential improving treatment (medicinal or not)

    through a questionnaire which identified potential improving treatment

    Time frame: Day 0 - visit of inclusion

  6. Impact on Quality Of Life through a questionnaire

    impact of cramps on their daily life

    Time frame: Day 0 - visit of inclusion

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2025; primary completion for Jul 2025, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2024
First posted
Dec 17, 2024
StartEst.
Jan 2025
Primary completionEst.
Jul 2025
CompletionEst.
Jul 2025
Last update
Dec 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06737094
Responsible party
Sponsor
First posted
Dec 17, 2024
Start date
Jan 2025 (estimated)
Primary completion
Jul 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Dec 17, 2024

Study contacts

Marie-Alyette Costa de Beauregard, MD
Contact
marie.costadebeauregard@aphp.fr
+ 33 1 42 17 72 03
Jean-Jacques Boffa, PU-PH
Contact
jean-jacques.boffa@aphp.fr
+33 (0) 1 56 01 60 29
Marie-Alyette Costa de Beauregard, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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