Chronic Kidney DiseasePhase 1/2PTX-CALC-CKDNCT06903689
Pentoxifylline for Vascular Calcification in Kidney Disease
A Phase 1/2 study testing Pentoxifylline 400 MG Oral Tablet and Conventional Medications for Chronic Kidney Disease in people with Chronic Kidney Disease and Vascular Calcification, run by Mansoura University.
Trial summary
This study is research to find out if the drug pentoxifylline can help prevent or lessen the problem of blood vessel hardening (vascular calcification) in people with chronic kidney disease (CKD). People with CKD are at higher risk for heart problems and blood vessel hardening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Vascular Calcification, Kidney Failure, Chronic
- What is being tested?
- Pentoxifylline 400 MG Oral Tablet and Conventional Medications for Chronic Kidney Disease
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 30 Oct 2025
- Phase
- Phase 1/2
- 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
Who may be able to join
- Estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m² and greater than or equal to 15 ml/min/1.73 m².
- Adult patients, age 18 years or older.
- Diagnosis of Chronic Kidney Disease (CKD).
- Willing and able to provide informed consent.
Who cannot join
- Patients currently undergoing regular hemodialysis.
- History of kidney transplantation or are kidney transplant recipients.
- Pregnant females.
- Patients with a history of coronary artery bypass grafting (CABG).
- Known allergy or contraindication to pentoxifylline.
- Inability to comply with study procedures or attend follow-up visits.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exploring the Potential Effect of Pentoxifylline in Mitigating Vascular Calcification in Chronic Kidney Disease Patients
This study is research to find out if the drug pentoxifylline can help prevent or lessen the problem of blood vessel hardening (vascular calcification) in people with chronic kidney disease (CKD). People with CKD are at higher risk for heart problems and blood vessel hardening. Vascular calcification happens when calcium builds up in the blood vessels, making them stiff. Pentoxifylline is a drug that might have helpful effects that could reduce this hardening. In this study, some CKD patients will receive pentoxifylline in addition to their usual medications, while others will only receive their usual medications. The researchers will then compare the amount of vascular calcification in both groups over 6 months to see if pentoxifylline makes a difference. The goal is to learn if pentoxifylline could be a new way to protect the blood vessels of people with chronic kidney disease.
- Being tested
- Pentoxifylline 400 MG Oral Tablet, Conventional Medications for Chronic Kidney Disease
- Keywords
- Kidney Failure, Chronic, Vascular Calcification, Pentoxifylline, CKD
- Medical subject headings
- Renal Insufficiency, Chronic, Vascular Calcification, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentoxifylline 400 MG Oral TabletDrug
Oral tablet, 400 mg, administered twice daily with food for 6 months. To be taken in addition to conventional medications for chronic kidney disease.
Conventional Medications for Chronic Kidney DiseaseOther
This arm receives conventional medical management for chronic kidney disease (CKD). This includes medications and treatments as deemed necessary and appropriate by the participant's treating physician, according to established clinical guidelines for CKD. These may include, but are not limited to, medications for blood pressure control, management of diabetes, anemia treatment, mineral and bone disorder management, and fluid and electrolyte balance management. The specific medications and treatments are individualized and not dictated by the study protocol, but follow standard clinical practice for CKD.
| Study group | Role | What they receive |
|---|---|---|
| Pentoxifylline Arm | Experimental | Participants in this arm will receive Pentoxifylline 400 mg twice daily orally with food, in addition to their conventional medications for chronic kidney disease (CKD). Pentoxifylline treatment will be administered for 6 months, concurrent with the study duration. Conventional medications will continue as prescribed by their treating physician and will be consistent with standard of care for CKD. Receives: Drug: Pentoxifylline 400 MG Oral Tablet |
| Conventional Medication Group | Active comparator | Participants in this arm will receive conventional medications for chronic kidney disease (CKD) only. They will not receive Pentoxifylline. Conventional medications will be administered as prescribed by their treating physician and will be consistent with standard of care for CKD. This arm serves as the control group to compare against the Pentoxifylline arm in evaluating the potential effect of Pentoxifylline on vascular calcification. Receives: Other: Conventional Medications for Chronic Kidney Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Agatston Coronary Artery Calcification Score from Baseline to 6 Months
The primary outcome measure is the change in coronary artery calcification as assessed by the Agatston score, measured from baseline to 6 months after the start of the intervention. Coronary artery calcification will be quantified using computed tomography (CT) scans and analyzed using the Agatston method. A higher Agatston score indicates a greater degree of coronary artery calcification. The change will be calculated as the difference between the Agatston score at 6 months and the Agatston score at baseline.
Measured: 6 Months
Secondary outcomes (1)
Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline to 6 Months
Change in estimated glomerular filtration rate (eGFR) will be assessed from baseline to 6 months. eGFR will be calculated using serum creatinine levels and a standard CKD-EPI equation. eGFR is a measure of kidney function, with lower values indicating poorer kidney function. The change will be calculated as the difference between the eGFR value at 6 months and the eGFR value at baseline.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Massoud Gaber, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903689
- Sponsor's protocol ID
- MS.24.09.2905
- Acronym
- PTX-CALC-CKD
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are currently undecided about IPD sharing. Factors under consideration include institutional data-sharing policies, ethical considerations related to participant privacy, and the resources required for data anonymization and preparation for sharing. A decision will be made as these factors are further evaluated.
Publications
Leporini C, Pisano A, Russo E, D Arrigo G, de Sarro G, Coppolino G, Bolignano D. Effect of pentoxifylline on renal outcomes in chronic kidney disease patients: A systematic review and meta-analysis. Pharmacol Res. 2016 May;107:315-332. doi: 10.1016/j.phrs.2016.03.001. Epub 2016 Mar 17.
PubMed 26995301de Morales AM, Goicoechea M, Verde E, Carbayo J, Barbieri D, Delgado A, Verdalles U, de Jose AP, Luno J. Pentoxifylline, progression of chronic kidney disease (CKD) and cardiovascular mortality: long-term follow-up of a randomized clinical trial. J Nephrol. 2019 Aug;32(4):581-587. doi: 10.1007/s40620-019-00607-0. Epub 2019 Apr 4.
PubMed 30949987Chen J, Budoff MJ, Reilly MP, Yang W, Rosas SE, Rahman M, Zhang X, Roy JA, Lustigova E, Nessel L, Ford V, Raj D, Porter AC, Soliman EZ, Wright JT Jr, Wolf M, He J; CRIC Investigators. Coronary Artery Calcification and Risk of Cardiovascular Disease and Death Among Patients With Chronic Kidney Disease. JAMA Cardiol. 2017 Jun 1;2(6):635-643. doi: 10.1001/jamacardio.2017.0363.
PubMed 28329057
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Potential Effect of Pentoxifylline in Mitigating Vascular Calcification in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT06903689
- Acronym / sponsor ID
- PTX-CALC-CKD / MS.24.09.2905
- Keywords
- Kidney Failure, Chronic, Vascular Calcification, Pentoxifylline, CKD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 1 Apr 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 is research to find out if the drug pentoxifylline can help prevent or lessen the problem of blood vessel hardening (vascular calcification) in people with chronic kidney disease (CKD). People with CKD are at higher risk for heart problems and blood vessel hardening. Vascular calcification happens when calcium builds up in the blood vessels, making them stiff. Pentoxifylline is a drug that might have helpful effects that could reduce this hardening. In this study, some CKD patients will receive pentoxifylline in addition to their usual medications, while others will only receive their usual medications. The researchers will then compare the amount of vascular calcification in both groups over 6 months to see if pentoxifylline makes a difference. The goal is to learn if pentoxifylline could be a new way to protect the blood vessels of people with chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentoxifylline Arm | Experimental | Drug: Pentoxifylline 400 MG Oral TabletParticipants in this arm will receive Pentoxifylline 400 mg twice daily orally with food, in addition to their conventional medications for chronic kidney disease (CKD). Pentoxifylline treatment will be administered for 6 months, concurrent with the study duration. Conventional medications will continue as prescribed by their treating physician and will be consistent with standard of care for CKD. |
| Conventional Medication Group | Active comparator | Other: Conventional Medications for Chronic Kidney DiseaseParticipants in this arm will receive conventional medications for chronic kidney disease (CKD) only. They will not receive Pentoxifylline. Conventional medications will be administered as prescribed by their treating physician and will be consistent with standard of care for CKD. This arm serves as the control group to compare against the Pentoxifylline arm in evaluating the potential effect of Pentoxifylline on vascular calcification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m² and greater than or equal to 15 ml/min/1.73 m².
- Adult patients, age 18 years or older.
- Diagnosis of Chronic Kidney Disease (CKD).
- Willing and able to provide informed consent.
Key exclusion criteria (6 listed)
- Patients currently undergoing regular hemodialysis.
- History of kidney transplantation or are kidney transplant recipients.
- Pregnant females.
- Patients with a history of coronary artery bypass grafting (CABG).
- Known allergy or contraindication to pentoxifylline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentoxifylline 400 MG Oral TabletOral tablet, 400 mg, administered twice daily with food for 6 months. To be taken in addition to conventional medications for chronic kidney disease. | Drug | Pentoxifylline Arm |
| Conventional Medications for Chronic Kidney DiseaseThis arm receives conventional medical management for chronic kidney disease (CKD). This includes medications and treatments as deemed necessary and appropriate by the participant's treating physician, according to established clinical guidelines for CKD. These may include, but are not limited to, medications for blood pressure control, management of diabetes, anemia treatment, mineral and bone disorder management, and fluid and electrolyte balance management. The specific medications and treatments are individualized and not dictated by the study protocol, but follow standard clinical practice for CKD. | Other | Conventional Medication Group |
Primary outcome
Change in Agatston Coronary Artery Calcification Score from Baseline to 6 Months
Time frame: 6 Months
The primary outcome measure is the change in coronary artery calcification as assessed by the Agatston score, measured from baseline to 6 months after the start of the intervention. Coronary artery calcification will be quantified using computed tomography (CT) scans and analyzed using the Agatston method. A higher Agatston score indicates a greater degree of coronary artery calcification. The change will be calculated as the difference between the Agatston score at 6 months and the Agatston score at baseline.
1 secondary outcome
Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline to 6 Months
Time frame: 6 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 1 Apr 2025.
- Background: PubMed 26995301Leporini C, Pisano A, Russo E, D Arrigo G, de Sarro G, Coppolino G, Bolignano D. Effect of pentoxifylline on renal outcomes in chronic kidney disease patients: A systematic review and meta-analysis. Pharmacol Res. 2016 May;107:315-332. doi: 10.1016/j.phrs.2016.03.001. Epub 2016 Mar 17.
- Background: PubMed 30949987de Morales AM, Goicoechea M, Verde E, Carbayo J, Barbieri D, Delgado A, Verdalles U, de Jose AP, Luno J. Pentoxifylline, progression of chronic kidney disease (CKD) and cardiovascular mortality: long-term follow-up of a randomized clinical trial. J Nephrol. 2019 Aug;32(4):581-587. doi: 10.1007/s40620-019-00607-0. Epub 2019 Apr 4.
- Background: PubMed 28329057Chen J, Budoff MJ, Reilly MP, Yang W, Rosas SE, Rahman M, Zhang X, Roy JA, Lustigova E, Nessel L, Ford V, Raj D, Porter AC, Soliman EZ, Wright JT Jr, Wolf M, He J; CRIC Investigators. Coronary Artery Calcification and Risk of Cardiovascular Disease and Death Among Patients With Chronic Kidney Disease. JAMA Cardiol. 2017 Jun 1;2(6):635-643. doi: 10.1001/jamacardio.2017.0363.
- Individual participant dataSharing planned: Undecided. We are currently undecided about IPD sharing. Factors under consideration include institutional data-sharing policies, ethical considerations related to participant privacy, and the resources required for data anonymization and preparation for sharing. A decision will be made as these factors are further evaluated.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pentoxifylline 400 MG Oral Tablet and Conventional Medications for Chronic Kidney Disease in people with Chronic Kidney Disease and Vascular Calcification, run by Mansoura University.
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 4 inclusion and 6 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 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dina M Gaber, M.B.B. Ch (+201010402101 ext. +201062376458, dinamasud11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Agatston Coronary Artery Calcification Score from Baseline to 6 Months (time frame: 6 Months). 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 NCT06903689, which also lists 3 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 1 Apr 2025.