The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum

Endstage Renal Disease Clinical Trial

Official title:

The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010072
• Other study ID #: PA21-T50-CKD5D
• Status: Completed
• Phase: Phase 2
• Start date: June 9, 2017
• Est. completion date: May 10, 2019

Study information

• Verified date: July 2019
• Source: Elisabethinen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-center, prospective, open-label, controlled, randomized, cross-over study in 34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with hyperphosphatemia.

Description:

Patients will be randomized in a 1:1 ratio to either receive low-dose (250mg/d) PA-21 followed by high-dose (2000mg/d) PA-21 (sequence A-B) or to receive high-dose PA21 followed by low-dose PA21 (sequence B-A) with washout-phases in between. An open label design with a sub-therapeutic dose of PA21 as control treatment was chosen because creating a convincing placebo for PA21 is not feasible.

The study will start with two study visits on the 2nd and 3rd dialysis session of the week , where dialysis patients are still treated with standard of care to establish baseline values (duration: 0.5 weeks). Next will be an initial run-in wash-out phase, where all phosphate binders taken by the patient as standard of care treatment will be discontinued and no phosphate binders will be introduced. Consequently, there will be a PA21 treatment (high dose/low dose) phase, followed by a wash-out phase, followed by another PA21 treatment (high dose/low dose) phase, followed by a final wash-out phase. Each study phase, including wash-out phases as well as low-dose and high-dose treatment phases will be 14 days of duration. Patients will be followed up to 10.5 weeks after randomization until the last study visit of the final wash-out phase.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 10, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prevalent patients (= 3 months on dialysis) treated with thrice weekly hemodialysis (HD) or hemodiafiltration (HDF)

• Hyperphosphatemia (serum phosphate > upper limit of normal within the last 3 months) or current phosphate binder use

• No use or constant dose of vitamin D and/or calcimimetics for =2 weeks

Exclusion Criteria:

• Allergy to sucroferric oxyhydroxide (PA21), to other ingredients of Velphoro or to any iron-medication

• Current or history of calciphylaxis (calcific uremic arteriolopathy - CUA)

• parathormone >800 pg/ml

• Parathyreoidektomie planned or expected

• Significant GI or hepatic disorders

• Hypercalcemia (total serum calcium >2.6 mmol/l) at screening

• Antacids containing aluminum, calcium, magnesium or bicarbonate

• Oral iron treatments/supplements

• Pregnant and nursing (lactating) women

Related Conditions & MeSH terms

• Calcinosis
• Endstage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• low-dose sucroferric oxyhydroxide
250 mg suroferric oxyhydroxide
• high-dose sucroferric oxyhydroxide
2000 mg suroferric oxyhydroxide

Locations

Country	Name	City	State
Austria	Ordensklinikum Linz GmbH Elisabethinen	Linz	Upper Austria

Sponsors (2)

Lead Sponsor	Collaborator
Prim. Priv. Doz. Dr. Daniel Cejka	Vifor Fresenius Medical Care Renal Pharma

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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