Dipyridamole for Low Phosphate

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Plavix, DOACs, Coumadin

Disqualifiers: Delayed graft function, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary goal is to determine if Dipyridamole can improve serum phosphate levels and reduce the need for phosphate supplementation.

Will I have to stop taking my current medications?

The trial requires that you stop taking Plavix, direct oral anticoagulants (DOACs), or Coumadin if you are currently using them.

Is the drug dipyridamole effective for treating low phosphate levels?

Research shows that dipyridamole did not change phosphate levels in children with X-linked hypophosphatemia, suggesting it may not be effective for treating low phosphate levels in this condition. ^{1 2 3 4 5}

Is dipyridamole safe for humans?

Dipyridamole has been used in studies with children and adults for conditions related to phosphate levels, and no significant safety issues were reported in these studies. ^{1 2 6 7 8}

How does the drug dipyridamole differ from other treatments for low phosphate?

Dipyridamole is unique because it is primarily known as an antiplatelet agent and coronary vasodilator, but it also has the potential to affect nucleoside metabolism, which might be relevant in conditions like low phosphate. Unlike standard treatments for low phosphate, which often involve direct phosphate supplementation, dipyridamole's mechanism may involve altering cellular processes related to nucleosides. ^{9 10 11 12 13}

Research Team

Stephan Busque, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for kidney transplant recipients who may be at risk of developing low phosphate levels (hypophosphatemia) after their surgery. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

I have received a kidney transplant.

I am not allergic or sensitive to Dipyridamole.

Exclusion Criteria

I cannot take Dipyridamole due to health reasons.

I needed dialysis within a week after my transplant.

I need to take Plavix, DOACs, or Coumadin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Dipyridamole in addition to standard post-transplant care

12 weeks

Visits at baseline, 1 week, 4 weeks, 8 weeks, 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dipyridamole

Trial Overview The trial is testing whether Dipyridamole, given at a dose of 75 MG, can help maintain healthy phosphate levels in the blood and reduce the necessity for additional phosphate supplements post-kidney transplant.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

Participants receive Dipyridamole in addition to standard post-transplant care.

Group II: Control Group Active Control 1 Intervention

Participants in this group will receive standard post-transplant care without Dipyridamole.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Elevated serum phosphorus levels are a significant risk factor for cardiovascular disease in patients with chronic kidney disease, making phosphate management crucial for improving cardiovascular health.

Current phosphate binders have limitations, including side effects and difficulty in adherence, leading to the need for new therapies like EOS789 and tenapanor, which target different intestinal phosphate absorption pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Past, Present, and Future of Phosphate Management. Doshi, SM., Wish, JB.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effect of dipyridamole on serum and urinary phosphate in X-linked hypophosphatemia. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Dipyridamole for renal phosphate leak in successfully renal transplanted hypophosphatemic patients. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

NaPi-IIb Inhibition for Hyperphosphatemia in CKD Hemodialysis Patients. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of a Nutritional Mobile Application for Management of Hyperphosphatemia in Patients on Hemodialysis: A Multicenter Open-Label Randomized Clinical Trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Patient empowerment in the management of hyperphosphatemia. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Past, Present, and Future of Phosphate Management. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Management of hypophosphatemia. [2005]

8. China pubmed.ncbi.nlm.nih.gov

Phosphate binders, appetite and nutritional status in maintenance hemodialysis patients. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Plasma uridine changes in cancer patients treated with the combination of dipyridamole and N-phosphonacetyl-L-aspartate. [2016]

10. Germany pubmed.ncbi.nlm.nih.gov

Effect of dipyridamole on fluorodeoxyuridine cytotoxicity in vitro and in cancer patients. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Dipyridamole bioavailability in subjects with reduced gastric acidity. [2013]

12. Hungary pubmed.ncbi.nlm.nih.gov

[A new drug in a new role: dipyridamole in the treatment of HIV-1 infections?]. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

Dipyridamole in the nephritides. [2019]