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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Dipyridamole can help individuals with low phosphate levels following a kidney transplant. The researchers aim to determine if it can improve phosphate levels and reduce the need for additional supplements. Participants will receive either Dipyridamole with their usual post-transplant care or just the standard care. Suitable candidates for this trial are adult kidney transplant patients who tolerate Dipyridamole and do not require specific blood-thinning medications. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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 there any evidence suggesting that Dipyridamole is likely to be safe for humans?

Earlier studies have used Dipyridamole in both children and adults for issues related to phosphate levels, and these studies did not find any major safety problems. Research also shows that Dipyridamole can improve kidney function and increase survival rates in people with chronic kidney disease, suggesting it is generally safe to use. Since this trial is in an early stage, Dipyridamole has shown some safety in humans, but more testing is needed to confirm its safety and effectiveness for this specific purpose. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for low phosphate, which often focus on dietary adjustments and phosphate supplements, Dipyridamole offers a novel approach. This drug is unique because it works by enhancing blood flow and potentially improving phosphate absorption at the cellular level. Researchers are excited about Dipyridamole because it not only complements the standard post-transplant care but may also provide a more efficient way to manage phosphate levels, potentially reducing the need for high doses of supplements. This could lead to better patient outcomes and fewer side effects associated with current treatments.

What evidence suggests that Dipyridamole might be an effective treatment for low phosphate?

Research has shown that dipyridamole can help improve low phosphate levels. In this trial, participants in the treatment group will receive dipyridamole alongside standard post-transplant care. One study found that patients who took 75 mg of dipyridamole four times a day had better phosphate levels and lost less phosphate through their kidneys. Another study found that adding dipyridamole to a treatment plan helped normalize both phosphorus and calcium levels. However, research in children did not show any change in phosphate levels with dipyridamole. Overall, dipyridamole has been linked to better kidney health, especially in adults. ^{1 2 4 6 7}

Who Is on the Research Team?

Stephan Busque, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/9644637/

Dipyridamole decreases renal phosphate leak and ...

Dipyridamole at a dose of 75 mg 4 times daily increases low TmPO4/GFR and improves hypophosphatemia in patients with renal phosphate losses.

2.

journals.lww.com

journals.lww.com/sjkd/fulltext/2015/26020/the_efficacy_of_dipyridamole_in_the_treatment_of.26.aspx

The Efficacy of Dipyridamole in the Treatment of...

Following the addition of dipyridamole to this treatment, the patient's serum phosphorus and calcium levels showed an increase to the normal level. Throughout ...

3.

withpower.com

withpower.com/trial/dipyridamole-for-low-phosphate-1e1db

Dipyridamole for Low Phosphate · Info for Participants

Is the drug dipyridamole effective for treating low phosphate levels? Research shows that dipyridamole did not change phosphate levels in children with X ...

4.

researchgate.net

researchgate.net/publication/268693335_Dipyridamole_treatment_is_associated_with_improved_renal_outcome_and_patient_survival_in_advanced_chronic_kidney_disease

Dipyridamole treatment is associated with improved renal ...

Our findings demonstrate that dipyridamole treatment is significantly associated with better renal outcomes and patient survival in patients with CKD stage 3–5.

5.

semanticscholar.org

semanticscholar.org/paper/Effect-of-dipyridamole-on-serum-and-urinary-in-Seikaly-Quigley/427df5434cdd8afe050db141a61fdad8fb46848c

Effect of dipyridamole on serum and urinary phosphate in X- ...

Dipyridamole decreases renal phosphate leak and augments serum phosphorus in patients with low renal phosphate threshold. · Medicine. Journal of the American ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S1607551X14002010

Dipyridamole treatment is associated with improved renal ...

Our findings demonstrate that dipyridamole treatment is significantly associated with better renal outcomes and patient survival in patients with CKD stage 3–5.

7.

emedicine.medscape.com

emedicine.medscape.com/article/242280-overview

Hypophosphatemia: Practice Essentials, Background, ...

Dipyridamole enhances renal tubular phosphate reabsorption and has been shown to be effective in posttransplant hypophosphatemia in small studies.