HemodyalysisNCT07141043
Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients
An observational study of Hemodyalysis and Kidney Tansplant, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
This study aims to integrate bone measurements (including bone turnover markers (BTM), bone mineral density (BMD) measurement, vertebral fracture assessment (VFA), trabecular bone score (TBS) ) commonly used in the general population for primary osteoporosis evaluation to enhance the assessment of CKD-MBD. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodyalysis, Kidney Tansplant, Osteoporosis
- How many people
- 180 participants
- Where
- 1 siteRomania
- Study dates
- 19 Mar 2025to Jun 2027
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50-70 years old and patients undergoing HD or KTR, aged 20-70 years old.
Who may be able to join
- HD group: Patients undergoing HD for at least 12 months, aged 20-70 years, after signing an informed consent.
- KTR group: Patients with successful KTx performed at least 12 months prior to their enrollment, aged 20-70 years old, after signing an informed consent. Subjects will be eligible for inclusion regardless of KTx immunosuppression regimen, pre-transplantation history, history of pre-transplant dialysis, or whether the kidney donation was from a living or deceased donor.
- GPO group: men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50-70 years old, after signing an informed consent.
Who cannot join
- HD group: Treatment with active bone therapies (excluding calcium and vitamin D); ongoing cancer treatment or recent history of malignancy, cirrhosis, recent major fractures, patients who have received transplants other than kidney, secondary causes of osteoporosis (other than CKD or transplant-related: primary hyperparathyroidism, hyperthyroidism, congenital bone disorders, sarcoidosis, severe bone trauma, malignant tumors, inflammatory bowel disease, endogenous Cushing syndrome, anti-estrogen/anti-androgen therapy, and anorexia nervosa), pregnancy and breast-feeding.
- KTR group: The same as for HD + return to dialysis + acute graft rejection.
- GPO group: The same as for HD + diabetes mellitus + prolonged glucocorticoid therapy (>7.5 mg Prednisone or equivalent for at least 3 months).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
University of Medicine and Pharmacy "Grigore T. Popa"
Iași
Nada Akad, Dr., akadnada@gmail.com
About this study
Official title: New Directions and Perspectives in the Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients
This study aims to integrate bone measurements (including bone turnover markers (BTM), bone mineral density (BMD) measurement, vertebral fracture assessment (VFA), trabecular bone score (TBS) ) commonly used in the general population for primary osteoporosis evaluation to enhance the assessment of CKD-MBD.
Read the detailed description
Prospective observational study that will evaluate differences in bone (BMD, TBS, VFA and BTMs, serum calcium and phosphate) parameters in hemodialysis (HD) patients and kidney transplant recipients (KTR), compared to general population osteopenia/osteoporosis patients, at baseline and after one year of monitoring, with or without therapeutic intervention for CKD-MBD (KTR and HD groups).
- Conditions
- Hemodyalysis, Kidney Tansplant, Osteoporosis, CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder
- Keywords
- CKD-MBD, Osteoporosis, bone turnover markers
- Medical subject headings
- Osteoporosis, Chronic Kidney Disease-Mineral and Bone Disorder
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 |
|---|---|---|
| Hemodialysis group | Patients undergoing HD for at least 12 months, aged 20-70 years, after signing an informed consent. | |
| Kidney transplant group | Patients with successful KTx performed at least 12 months prior to their enrollment, aged 20-70 years old, after signing an informed consent. Subjects will be eligible for inclusion regardless of KTx immunosuppression regimen, pre-transplantation history, history of pre-transplant dialysis, or whether the kidney donation was from a living or deceased donor. | |
| General population osteoporosis/osteopenia | Men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50-70 years old, after signing an informed consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BTM Levels in KTx recipients (KTR) compared to HD patients and general population osteopenia/osteoporosis (GPO) patients.
Longitudinal assessment of BTMs, including serum procollagen type I N-terminal propeptide (P1NP), osteocalcin, bone specific alkaline phosphatase (BAP), C-terminal telopeptide of type I collagen (CTX) and tartrate-resistant acid phosphatase 5b (TRAP5b) in KTR compared with HD patients and GPO patients.
Measured: 12 months
Secondary outcomes (3)
Correlation Between BTM Levels and BMD in KTR compared with HD and GPO patients.
Correlation analysis between BTM levels (procollagen type I N-terminal propeptide (P1NP), osteocalcin, bone specific alkaline phosphatase (BAP), C-terminal telopeptide of type I collagen (CTX) and tartrate-resistant acid phosphatase 5b (TRAP5b)) and BMD (g/cm²) assessed by dual-energy X-ray absorptiometry (DXA) at the lumbar spine, femoral neck and forearm. Data will be stratified by study group (KTR, HD and GPO patients) and by gender. Correlation coefficients will be reported for each group.
Measured: 12 months
Correlation Between BTM Levels and TBS in KTR compared with HD and GPO patients.
Correlation analysis between BTM levels (procollagen type I N-terminal propeptide (P1NP), osteocalcin, bone specific alkaline phosphatase (BAP), C-terminal telopeptide of type I collagen (CTX) and tartrate-resistant acid phosphatase 5b (TRAP5b)) and TBS (unitless index) derived from DXA images at the lumbar spine. Data will be stratified by study group (KTR, HD and GPO patients) and by gender. Correlation coefficients will be reported for each group.
Measured: 12 months
Key BTMs Predicting Bone Health Outcomes in KTR Patients
Correlation between change from baseline in BTM and change from baseline in TBS.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start19 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodyalysisStudies of the same condition, open and under way.
- 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akad Nada, Grigore T. Popa University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141043
- Sponsor's protocol ID
- Nr. 501/30.11.2024
- Status last verified
- Aug 2025
- First submitted
- 28 Jun 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy concerns and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Directions and Perspectives in the Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT07141043
- Acronym / sponsor ID
- Nr. 501/30.11.2024
- Conditions
- Hemodyalysis, Kidney Tansplant, Osteoporosis, CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder
- Keywords
- CKD-MBD, Osteoporosis, bone turnover markers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Aug 2025 (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.
This study aims to integrate bone measurements (including bone turnover markers (BTM), bone mineral density (BMD) measurement, vertebral fracture assessment (VFA), trabecular bone score (TBS) ) commonly used in the general population for primary osteoporosis evaluation to enhance the assessment of CKD-MBD.
Detailed description
Prospective observational study that will evaluate differences in bone (BMD, TBS, VFA and BTMs, serum calcium and phosphate) parameters in hemodialysis (HD) patients and kidney transplant recipients (KTR), compared to general population osteopenia/osteoporosis patients, at baseline and after one year of monitoring, with or without therapeutic intervention for CKD-MBD (KTR and HD groups).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis group | – | –Patients undergoing HD for at least 12 months, aged 20-70 years, after signing an informed consent. |
| Kidney transplant group | – | –Patients with successful KTx performed at least 12 months prior to their enrollment, aged 20-70 years old, after signing an informed consent. Subjects will be eligible for inclusion regardless of KTx immunosuppression regimen, pre-transplantation history, history of pre-transplant dialysis, or whether the kidney donation was from a living or deceased donor. |
| General population osteoporosis/osteopenia | – | –Men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50-70 years old, after signing an informed consent. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50-70 years old and patients undergoing HD or KTR, aged 20-70 years old.
Key inclusion criteria (3 listed)
- HD group: Patients undergoing HD for at least 12 months, aged 20-70 years, after signing an informed consent.
- KTR group: Patients with successful KTx performed at least 12 months prior to their enrollment, aged 20-70 years old, after signing an informed consent. Subjects will be eligible for inclusion regardless of KTx immunosuppression regimen, pre-transplantation history, history of pre-transplant dialysis, or whether the kidney donation was from a living or deceased donor.
- GPO group: men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50-70 years old, after signing an informed consent.
Key exclusion criteria (3 listed)
- HD group: Treatment with active bone therapies (excluding calcium and vitamin D); ongoing cancer treatment or recent history of malignancy, cirrhosis, recent major fractures, patients who have received transplants other than kidney, secondary causes of osteoporosis (other than CKD or transplant-related: primary hyperparathyroidism, hyperthyroidism, congenital bone disorders, sarcoidosis, severe bone trauma, malignant tumors, inflammatory bowel disease, endogenous Cushing syndrome, anti-estrogen/anti-androgen therapy, and anorexia nervosa), pregnancy and breast-feeding.
- KTR group: The same as for HD + return to dialysis + acute graft rejection.
- GPO group: The same as for HD + diabetes mellitus + prolonged glucocorticoid therapy (>7.5 mg Prednisone or equivalent for at least 3 months).
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
Change in BTM Levels in KTx recipients (KTR) compared to HD patients and general population osteopenia/osteoporosis (GPO) patients.
Time frame: 12 months
Longitudinal assessment of BTMs, including serum procollagen type I N-terminal propeptide (P1NP), osteocalcin, bone specific alkaline phosphatase (BAP), C-terminal telopeptide of type I collagen (CTX) and tartrate-resistant acid phosphatase 5b (TRAP5b) in KTR compared with HD patients and GPO patients.
3 secondary outcomes
Correlation Between BTM Levels and BMD in KTR compared with HD and GPO patients.
Time frame: 12 months
Correlation Between BTM Levels and TBS in KTR compared with HD and GPO patients.
Time frame: 12 months
Key BTMs Predicting Bone Health Outcomes in KTR Patients
Time frame: 12 months
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 26 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy concerns and data protection regulations.
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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.
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 Hemodyalysis and Kidney Tansplant, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 26 Aug 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 Romania. 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 Nada Akad, Dr. (0040742015245, akadnada@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BTM Levels in KTx recipients (KTR) compared to HD patients and general population osteopenia/osteoporosis (GPO) patients. (time frame: 12 months). 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 26 Aug 2025.