PentoxifyllineNCT07561801
Pentoxifylline for Prevention of Contrast Induced Nephropathy in Chronic Kidney Diseased Patients in Intensive Care Unit
A study testing Pentoxifylline and Normal saline in people with Pentoxifylline and Contrast Induced Nephropathy, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of pentoxifylline for control of contrast induced nephropathy in chronic kidney diseased patients in intensive care unit. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pentoxifylline, Contrast Induced Nephropathy, Chronic Kidney Disease
- What is being tested?
- Pentoxifylline and Normal saline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Jun 2025
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both sexes.
- The presence of chronic kidney disease (CKD) is defined according to the National Kidney Foundation-kidney disease Outcomes Quality Initiative guidelines with second or third stage.
- Urgent patients expected taking dye in stable cases of cardiac catheterization or pulmonary embolism with Geneva score (4-11).
Who cannot join
- Patients with CKD on renal replacement therapy.
- Respiratory failure.
- Cardiac failure.
- Liver failure.
- Methylxanthines hypersensitivity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Pentoxifylline for Prevention of Contrast Induced Nephropathy in Chronic Kidney Diseased Patients in Intensive Care Unit
The aim of this study is to evaluate the effect of pentoxifylline for control of contrast induced nephropathy in chronic kidney diseased patients in intensive care unit.
Read the detailed description
Contrast-induced acute kidney injury (AKI), which is also known as contrast-induced nephropathy (CIN), is defined as the development of AKI following contrast medium exposure, without an alternative aetiology.
Recently, the cyclic nucleotide phosphodiesterase (PDE) has emerged as a promising target for pharmacological intervention against chronic kidney disease (CKD) progression.
The nonselective PDE inhibitor pentoxifylline (PTX) is a methyl xanthine derivative. It's an old drug that exhibits prominent anti-inflammatory, anti-proliferative and anti-fibrotic activities both in vitro and in vivo. In addition to its classic indication for intermittent claudication. It has been used primarily to treat patients with peripheral arterial insufficiency.
- Being tested
- Pentoxifylline, Normal saline
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Patients received hydration (100ml normal saline every hour (2400ml/day) with closed dynamic monitoring of the blood volume and 400 mg oral Pentoxifylline (PTX) three times per day [dose adjustment according to estimated glomerular filtration rate (eGFR)] from 24 hr before contrast to 48 hr after contrast procedure.
Normal salineDrug
Patient received hydration (100ml normal saline every hour (2400ml/day) with closed dynamic monitoring of the blood volume and placebo with same shape and color of Pentoxifylline (PTX) three times per day from 24 hr before contrast to 48 hr after contrast procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients received hydration (100ml normal saline every hour (2400ml/day) with closed dynamic monitoring of the blood volume and 400 mg oral Pentoxifylline (PTX) three times per day [dose adjustment according to estimated glomerular filtration rate (eGFR)] from 24 hr before contrast to 48 hr after contrast procedure. Receives: Drug: Pentoxifylline |
| Group II | Active comparator | Patient received hydration (100ml normal saline every hour (2400ml/day) with closed dynamic monitoring of the blood volume and placebo with same shape and color of Pentoxifylline (PTX) three times per day from 24 hr before contrast to 48 hr after contrast procedure. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of contrast induced nephropathy
Incidence of contrast induced nephropathy was recorded.
Measured: 48 hours after contrast procedure.
Secondary outcomes (3)
Progress of glomerular filtration rate
Progress of glomerular filtration rate after use of pentoxifylline was recorded.
Measured: 48 hours after contrast procedure.
Lenght of intensive care unit stay
Lenght of intensive care unit stay was recorded.
Measured: Till the end of procedure (Up to 4 hours)
Need of dialysis
Need of dialysis was recorded.
Measured: 48 hours after contrast procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jul 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PentoxifyllineStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Samy Mohamed Mostafa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561801
- Sponsor's protocol ID
- 36264MS591/5/24
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pentoxifylline for Prevention of Contrast Induced Nephropathy in Chronic Kidney Diseased Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07561801
- Acronym / sponsor ID
- 36264MS591/5/24
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 1 May 2026 (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.
The aim of this study is to evaluate the effect of pentoxifylline for control of contrast induced nephropathy in chronic kidney diseased patients in intensive care unit.
Detailed description
Contrast-induced acute kidney injury (AKI), which is also known as contrast-induced nephropathy (CIN), is defined as the development of AKI following contrast medium exposure, without an alternative aetiology.
Recently, the cyclic nucleotide phosphodiesterase (PDE) has emerged as a promising target for pharmacological intervention against chronic kidney disease (CKD) progression.
The nonselective PDE inhibitor pentoxifylline (PTX) is a methyl xanthine derivative. It's an old drug that exhibits prominent anti-inflammatory, anti-proliferative and anti-fibrotic activities both in vitro and in vivo. In addition to its classic indication for intermittent claudication. It has been used primarily to treat patients with peripheral arterial insufficiency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: PentoxifyllinePatients received hydration (100ml normal saline every hour (2400ml/day) with closed dynamic monitoring of the blood volume and 400 mg oral Pentoxifylline (PTX) three times per day [dose adjustment according to estimated glomerular filtration rate (eGFR)] from 24 hr before contrast to 48 hr after contrast procedure. |
| Group II | Active comparator | Drug: Normal salinePatient received hydration (100ml normal saline every hour (2400ml/day) with closed dynamic monitoring of the blood volume and placebo with same shape and color of Pentoxifylline (PTX) three times per day from 24 hr before contrast to 48 hr after contrast procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 65 years.
- Both sexes.
- The presence of chronic kidney disease (CKD) is defined according to the National Kidney Foundation-kidney disease Outcomes Quality Initiative guidelines with second or third stage.
- Urgent patients expected taking dye in stable cases of cardiac catheterization or pulmonary embolism with Geneva score (4-11).
Key exclusion criteria (5 listed)
- Patients with CKD on renal replacement therapy.
- Respiratory failure.
- Cardiac failure.
- Liver failure.
- Methylxanthines hypersensitivity.
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 |
|---|---|---|
| PentoxifyllinePatients received hydration (100ml normal saline every hour (2400ml/day) with closed dynamic monitoring of the blood volume and 400 mg oral Pentoxifylline (PTX) three times per day [dose adjustment according to estimated glomerular filtration rate (eGFR)] from 24 hr before contrast to 48 hr after contrast procedure. | Drug | Group I |
| Normal salinePatient received hydration (100ml normal saline every hour (2400ml/day) with closed dynamic monitoring of the blood volume and placebo with same shape and color of Pentoxifylline (PTX) three times per day from 24 hr before contrast to 48 hr after contrast procedure. | Drug | Group II |
Primary outcome
Incidence of contrast induced nephropathy
Time frame: 48 hours after contrast procedure.
Incidence of contrast induced nephropathy was recorded.
3 secondary outcomes
Progress of glomerular filtration rate
Time frame: 48 hours after contrast procedure.
Lenght of intensive care unit stay
Time frame: Till the end of procedure (Up to 4 hours)
Need of dialysis
Time frame: 48 hours after contrast procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pentoxifylline and Normal saline in people with Pentoxifylline and Contrast Induced Nephropathy, run by Tanta University at 1 site in Egypt.
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 5 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 1 May 2026. 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 Egypt. 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?
Incidence of contrast induced nephropathy (time frame: 48 hours after contrast procedure.). 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 1 May 2026.