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Oral Pyrophosphate Absorption in PXE Disease

NCT04441671 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-04-22

No results posted yet for this study

Summary

Pyrophosphate is an endogenous, non-toxic metabolite inhibiting soft tissue calcification. The aim of our study is to find optimal dosing and safety of oral disodium-PPi (Na2H2PPi). Absorption curves (pharmacokinetics), AUC0-t, Cmax and Tmax for PPi and phosphate will be provided for healthy controls and PXE-patients both fasting and with standard meal intake.

Conditions

  • Pseudoxanthoma Elasticum

Interventions

DRUG

Disodium Pyrophosphate

Absorption trial

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER

  • Hungarian Academy of Sciences

    collaborator OTHER

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Pasi I Nevalainen, MD, PhD · Tampere University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-08
Primary Completion
2021-04-01
Completion
2021-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04441671 on ClinicalTrials.gov