Evaluation of Dipyridamole in Preventing Post-Transplant Hypophosphatemia in Kidney Transplant Recipients

NCT06824454 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 76830
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypophosphatemia; Kidney Transplantation

Keywords

Post-kidney transplant care; Dipyridamole; Renal phosphate loss; Serum phosphate levels; Phosphate supplementation; Transplant graft function; Kidney transplant complications

Outcome Measures

Primary Outcomes (1)

• Change in Serum Phosphorus Levels After Dipyridamole Administration

  This study will evaluate the effectiveness of Dipyridamole in increasing serum phosphorus levels in kidney transplant recipients with hypophosphatemia.

  Baseline, 1 week, 4 weeks, 8 weeks, 12 weeks, and after stopping medicatio

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Drug: Dipyridamole 75 MG

Control Group

NO INTERVENTION

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

Interventions

Dipyridamole 75 MG DRUG

Dipyridamole administered three times daily when serum phosphorus levels fall below 4 mg/dL. The drug is used off-label for this study to manage hypophosphatemia in kidney transplant recipients.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult kidney transplant patients.
• No known contraindications to Dipyridamole

You may not qualify if:

• Contraindications to Dipyridamole.
• Patients with delayed graft function (defined as the need for dialysis within seven days post-transplantation).
• Patients requiring Plavix, direct oral anticoagulants (DOACs), or Coumadin.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Hypophosphatemia

Interventions

Dipyridamole

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stephan Busque, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery (Abdominal Transplantation)

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)