| Trial ID: | L0422 |
| Source ID: | NCT03010072
|
| Associated Drug: |
Low-Dose Sucroferric Oxyhydroxide
|
| Title: |
The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Endstage Renal Disease
|
| Interventions: |
DRUG: low-dose sucroferric oxyhydroxide|DRUG: high-dose sucroferric oxyhydroxide
|
| Outcome Measures: |
Primary: Propensity of serum for calcification - H1, The primary outcome is change in the mean T50- Test values between different study phases (wash-out/treatment/control)., 10.5 weeks | Secondary: Change in Serum Phosphate, The secondary outcome is the Change of mean Serum Phosphate Levels between different study visits, 10.5 weeks
|
| Sponsor/Collaborators: |
Sponsor: Prim. Priv. Doz. Dr. Daniel Cejka | Collaborators: Vifor Fresenius Medical Care Renal Pharma
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: DIAGNOSTIC
|
| Start Date: |
2017-06-09
|
| Completion Date: |
2019-05-10
|
| Results First Posted: |
|
| Last Update Posted: |
2019-07-22
|
| Locations: |
Ordensklinikum Linz GmbH Elisabethinen, Linz, Upper Austria, 4020, Austria
|
| URL: |
https://clinicaltrials.gov/show/NCT03010072
|
