CrampsCRAMéREINNCT06737094
Prevalence and Severity of Cramps in Chronic Kidney Disease Patients
An observational study of Cramps and Chronic Kidney Disease(CKD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cramps, Chronic Kidney Disease(CKD)
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2025to Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every patient with Chronic Kidney Disease (non dialysis and dialysis patients)
Who may be able to join
- Voluntary patients with CKD III to V (GFR<60ml/mn/1,72M2), including dialysed patients (hemodialysis or peritoneal dialysis).
- Non opposed to participate to the research.
Who cannot join
- Transplanted patient with functional graft.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Pitié Salpêtrière Service de néphrologie
Paris, 75013
Marie-Alyette Costa de Beauregard, MD, + 33 1 42 17 72 03, marie.costadebeauregard@aphp.fr
About this study
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.
- Conditions
- Cramps, Chronic Kidney Disease(CKD)
- Keywords
- Cramps, Chronic Kidney Disease, Pain
- Medical subject headings
- Muscle Cramp, Renal Insufficiency, Chronic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney Disease (CKD) Patients | Patients with CKD stade III to V (dialysis and non dialysis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cramps in CKD III-V patients. Number of patients having cramps / number of questionned patients
Measured: Day 0 - visit of inclusion
Secondary outcomes (6)
Measure of Severity of cramps
with a scale
Measured: Day 0 - visit of inclusion
Frequency of pain intensity
Measured: Day 0 - visit of inclusion
Identification of potential triggering factors
through a questionnaire triggering factors will be identified
Measured: Day 0 - visit of inclusion
Identification of associated factors (ionic desorders, medical treatment, degree of CKD, …)
Measured: Day 0 - visit of inclusion
Identification of potential improving treatment (medicinal or not)
through a questionnaire which identified potential improving treatment
Measured: Day 0 - visit of inclusion
Impact on Quality Of Life through a questionnaire
impact of cramps on their daily life
Measured: Day 0 - visit of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CrampsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Alyette Costa de Beauregard, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737094
- Sponsor's protocol ID
- APHP240246
- Other IDs
- IDRCB-2024-A00304-43
- Acronym
- CRAMéREIN
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Severity of Cramps in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT06737094
- Acronym / sponsor ID
- CRAMéREIN / APHP240246
- Conditions
- Cramps, Chronic Kidney Disease(CKD)
- Keywords
- Cramps, Chronic Kidney Disease, Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease (CKD) Patients | – | –Patients with CKD stade III to V (dialysis and non dialysis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient with Chronic Kidney Disease (non dialysis and dialysis patients)
Key inclusion criteria (2 listed)
- Voluntary patients with CKD III to V (GFR<60ml/mn/1,72M2), including dialysed patients (hemodialysis or peritoneal dialysis).
- Non opposed to participate to the research.
Key exclusion criteria (1 listed)
- Transplanted patient with functional graft.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of cramps in CKD III-V patients. Number of patients having cramps / number of questionned patients
Time frame: Day 0 - visit of inclusion
6 secondary outcomes
Measure of Severity of cramps
Time frame: Day 0 - visit of inclusion
Frequency of pain intensity
Time frame: Day 0 - visit of inclusion
Identification of potential triggering factors
Time frame: Day 0 - visit of inclusion
Identification of associated factors (ionic desorders, medical treatment, degree of CKD, …)
Time frame: Day 0 - visit of inclusion
Identification of potential improving treatment (medicinal or not)
Time frame: Day 0 - visit of inclusion
Impact on Quality Of Life through a questionnaire
Time frame: Day 0 - visit of inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Alyette Costa de Beauregard, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cramps and Chronic Kidney Disease(CKD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 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: opening soon, as of the sponsor's last update on 17 Dec 2024. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Alyette Costa de Beauregard, MD (+ 33 1 42 17 72 03, marie.costadebeauregard@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of cramps in CKD III-V patients. Number of patients having cramps / number of questionned patients (time frame: Day 0 - visit of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2024.