Status:
UNKNOWN
mHealth for Phosphorus Management in CKD.
Lead Sponsor:
Hospital Universitari de Bellvitge
Collaborating Sponsors:
Vifor Pharma
Conditions:
Dialysis Related Complication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The project aims to generate an mHealth environment in which CKD patients are empowered in terms of the self-management of their hyperphosphatemia pathology, while under medical supervision. Such envi...
Detailed Description
The working hypotheses are listed as follows: 1. Hyperphosphatemia is an important problem in the CKD realm, but difficult to manage because patients are often not aware of its importance. In additio...
Eligibility Criteria
Inclusion
- 1- Eligible patients will be stage 4-5 CKD patients, including end-stage renal disease (ESRD) on dialysis, aged \>18 with hyperphosphatemia (serum phosphorus concentration \>1.94 mmol/L) and stable dose of phosphate binders for \>1 month before screening.
Exclusion
- Patients with intact parathyroid hormone concentration \>800 ng/l (88 pmol/l) or if parathyroidectomy will be planned or expected.
- Patients with significant gastro-intestinal (GI) or hepatic disorders.
- Patients with major GI surgery.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05389826
Start Date
June 1 2022
End Date
October 15 2023
Last Update
September 22 2023
Active Locations (1)
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1
Hospital Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907