Contrast-induced NephropathyEarly Phase 1NCT07291375
Role of Amlodipine in Reduction of CIN
A Early Phase 1 study testing Calcium channel blocker and Hydration in people with Contrast-induced Nephropathy, run by Minia University.
Trial summary
The aim is to assess the benefit of low dose oral amlodipine in renal protection from contrast induced nephropathy in diabetic patients in intensive care unit Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Contrast-induced Nephropathy
- What is being tested?
- Calcium channel blocker and Hydration
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 1 Jul 2026
- Phase
- Early Phase 1
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients of both sexes (18:70) diabetic patients with serum creatinine below 1.2 hemodynamically stable patients ASA physical status 2,3
Who cannot join
- patient refusal patients of chronic kidney diseases NPO patients serum creatinine above 1.2 Hypertensive patients
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: The Effect of Low Dose Oral Amlodipine in Renal Protection From Contrast Induced Nephropathy in Diabetic Patients in Intensive Care Unit
The aim is to assess the benefit of low dose oral amlodipine in renal protection from contrast induced nephropathy in diabetic patients in intensive care unit
- Conditions
- Contrast-induced Nephropathy
- Being tested
- Calcium channel blocker, Hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium channel blockerDrug
Also called amlodipine ( 5mg)
amlodipine group will receive low dose oral amlodipine ( 5 mg ) before iv contrast and every 12 hour for 48 hour
HydrationOther
before the procedure patients will recieve iv bolus of 250 ml saline followed by continous infusion of 100 ml/h of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | this group who undergoing iv contrast will receive hydration only Receives: Other: Hydration |
| Amlodipine group | Other | this group will receive hydration and amlodipine Receives: Drug: Calcium channel blocker; Other: Hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring serum creatinine level
measuring serum creatinine level before the procedure and every day for 48 hours after
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast-induced NephropathyStudies of the same condition, open and under way.
- More trials run by Minia 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Samy Shafeek Shehata, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291375
- Sponsor's protocol ID
- Amlodipine role in CIN
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Dose Oral Amlodipine in Renal Protection From Contrast Induced Nephropathy in Diabetic Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07291375
- Acronym / sponsor ID
- Amlodipine role in CIN
- Conditions
- Contrast-induced Nephropathy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 18 Dec 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.
The aim is to assess the benefit of low dose oral amlodipine in renal protection from contrast induced nephropathy in diabetic patients in intensive care unit
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Hydrationthis group who undergoing iv contrast will receive hydration only |
| Amlodipine group | Other | Drug: Calcium channel blocker, Other: Hydrationthis group will receive hydration and amlodipine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients of both sexes (18:70) diabetic patients with serum creatinine below 1.2 hemodynamically stable patients ASA physical status 2,3
Key exclusion criteria (1 listed)
- patient refusal patients of chronic kidney diseases NPO patients serum creatinine above 1.2 Hypertensive patients
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 |
|---|---|---|
| Calcium channel blockerAlso: amlodipine ( 5mg)amlodipine group will receive low dose oral amlodipine ( 5 mg ) before iv contrast and every 12 hour for 48 hour | Drug | Amlodipine group |
| Hydrationbefore the procedure patients will recieve iv bolus of 250 ml saline followed by continous infusion of 100 ml/h of normal saline | Other | Amlodipine group, Control group |
Primary outcome
measuring serum creatinine level
Time frame: baseline
measuring serum creatinine level before the procedure and every day for 48 hours after
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 18 Dec 2025.
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Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
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Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
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ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
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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 Early Phase 1 study testing Calcium channel blocker and Hydration in people with Contrast-induced Nephropathy, run by Minia 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 1 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 18 Dec 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Andrew Shehata, Master (0201067820073, andrewlengouini.95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring serum creatinine level (time frame: baseline). 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 18 Dec 2025.