Evaluation of Calcium Acetate/Magnesium Carbonate (OsvaRen®) compared to Sevelamer (Renagel®) in Haemodialysis Patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 248

Inclusion Criteria

1.Patients of either sex aged 18-85 years.
2.Patients stable on 3x/week haemodialysis or online haemodiafiltration for at least three months, and who will continue to receive 4-6 hours haemodialysis 3x/week.
3.Patients willing to maintain an unchanged diet and dialysis regimen during washout/run-in and treatment phases of the study.
4.Patients requiring oral therapy with a phosphate binder.
5.Patients whose serum phosphorus is = 1.78 mmol/L (5.5 mg/dL) after washout of phosphate binder
6.Patients who are either on a stable dose of vitamin D and/or of calcimimetics for at least one month or do not require vitamin D therapy or calcimimetics.
7.Patients whose single pool Kt/V is > 1.4 or whose double pool Kt/V is > 1.2 according last measurement before Screening.
8.Patients who agree to discontinue the consumption of any other calcium or magnesium supplement or antacid containing Al, Mg or Ca during study participation.
9.Patients who have a life expectancy not shorter than the duration of the study.
10.Patients willing to comply with the study protocol.
11.Patients who are able to understand and provide written informed consent to participate in the trial (signed informed consent).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients with known hypersensitivity to any component of the trial drugs.
2.Patients with intact parathyroid hormone (iPTH) level < 100 or > 800 pg/ml according to last routine measurement before Screening.
3.Patients whose serum magnesium is > 1.5 mmol/L at the end of the washout/run-in period.
4.Patients whose serum calcium is > ULN at the end of the washout/run-in period.
5.Patients with heart failure NYHA class 3-4.
6.Patients with catheter access.
7.Patients with known acute or chronic infections.
8.Patients with malignant hypertension.
9.Patients with acute gastrointestinal bleeding.
10.Patients with active malignancies.
11.Patients with myasthenia gravis.
12.Patients with active inflammatory bowel disease or ileus.
13.Patients with uncontrolled, clinically significant AV block grade III, AV block grade II with bradycardia or with brady-arrhythmias.
14.Patients with current or past alcohol or drug abuse within the last 2 years before screening.
15.Patients participating in a clinical trial within the last 30 days before Day 1.
16.Any serious medical condition, which would hinder the patient’s ability to fully comply with the protocol.
17.Female patients of childbearing potential with a positive pregnancy test, breast feeding, or female patients of childbearing potential without adequate contraception.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the present study is to show the non-inferiority regarding phosphate binding in the OsvaRen® Group compared to the Renagel® Group.;Secondary Objective: Safety and tolerability;Primary end point(s): •Serum phosphorus at Week 25

Secondary Outcome Measures

Name	Time	Method

Related Trials