Intensive Phosphate Control in Development of Renal End Points and Mortality in CKD (the IPeR Study)

Intensive Phosphate Control in Development of Renal End Points and Mortality in CKD (the IPeR Study) - IPeR Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004888-41-IT

Enrollment

713

Registered

2012-12-11

Start date

2012-12-28

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Chronic Kidney Disease (CKD) not yet on dialysis MedDRA version: 14.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 100000004857

Interventions

Trade Name: OSVAREN*FL 180CPR RIV435+235MG Pharmaceutical Form: Tablet INN or Proposed INN: CALCIUM ACETATE CAS Number: 62-54-4 Current Sponsor code: Calcio Acetato + Magnesio carbonato Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with CKD not requiring dialysis and with eGFR of 15-60 ml/.min/1.73m2 by using CKD-EPI equation and phosphorus level >3,8 mg/dL - Patients have to be aged 18 years or older - Patients should be willing and able to provide written informed consent to participate in study Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 175 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 538

Exclusion criteria

Exclusion criteria: - Patients with current malignancy - Women who are pregnant, capable of becoming pregnant and not participating in an acceptable form of birth control - Patients with chronic gastrointestinal diseases that could impede their absorptive ability such as Crohn's disease, ulcerative colitis and sprue - Patients who have liver insufficiency - Patients with a history of solid organ transplantation - Patients with a rapid changes of GFR (more than - 5 mL/min within 90 days of enrollment in this study ) - Patients with PTH > 500 pcg/mL - Patients with a persistent hypercalcemia (> 11 mg/dL) - Patients in maintenance therapy with phosphate binders - Subjects with a non-compliance to dietary and pharmacological prescriptons - Subjects who are unable to independently provide written informed consent - Subjects with inability to perform a urinary collection of 24 hours - Patients with malnutrition (plasma albumin 2g/24 hours - Patients currently participating in a clinical trial with another investigational drug or device or who have receiving an investigational drug or device within 90 days of enrollment in this study

Design outcomes

Primary

Measure	Time frame
Main Objective: determine whether, in patients with Chronic Kidney Disease (CKD) not yet on dialysis, achieve and maintain in a relatively early stage of chronic kidney levels of phosphorus to the lower limit of normal and still below what is recommended by current guidelines, involves a reduction in the rate of progression of CKD and therefore the number of people who come to dialysis and CV mortality, which weighs heavily on patients with CKD. The primary objective of the study is to compare the control group and the intervention group compared to 'end point composite of death from any cause and from the entrance on dialysis.;Secondary Objective: -changes in serum phosphorus, changes in fractional urine phosphorus excretion, in serum parathyroid hormone, and FGF-23 -annual decline in GFR -cardiovascular events: (acute myocardial infarction, stroke, coronary arterial revascularization) -changes in arterial calcifications by using Kauppila score;Primary end point(s): percentage of composite events (death from any cause and any input on dialysis) and composite event time, starting from the entrance into the study. All efficacy assessments will be carried out in accordance with the principle of 'Intention-to-treat analysis (evaluation of all patients initially randomized to one of two types of treatment (usual care or intensive treatment of phosphorus) irrespective of the completion of the study and regardless of the assumption of a rescue therapy. addition Intention-to-treat analysis, an analysis will be performed per protocol patients who completed the study. This endpoint is considered to be of utmost clinical importance because it represents the combination of the two possible events that can occur in CKD 3-5. This outcome will be assessed by the investigator and documented in the CRF;Timepoint(s) of evaluation of this end point: 24 months	—

Measure

Time frame

Main Objective: determine whether, in patients with Chronic Kidney Disease (CKD) not yet on dialysis, achieve and maintain in a relatively early stage of chronic kidney levels of phosphorus to the lower limit of normal and still below what is recommended by current guidelines, involves a reduction in the rate of progression of CKD and therefore the number of people who come to dialysis and CV mortality, which weighs heavily on patients with CKD. The primary objective of the study is to compare the control group and the intervention group compared to 'end point composite of death from any cause and from the entrance on dialysis.;Secondary Objective: -changes in serum phosphorus, changes in fractional urine phosphorus excretion, in serum parathyroid hormone, and FGF-23 -annual decline in GFR -cardiovascular events: (acute myocardial infarction, stroke, coronary arterial revascularization) -changes in arterial calcifications by using Kauppila score;Primary end point(s): percentage of composite events (death from any cause and any input on dialysis) and composite event time, starting from the entrance into the study. All efficacy assessments will be carried out in accordance with the principle of 'Intention-to-treat analysis (evaluation of all patients initially randomized to one of two types of treatment (usual care or intensive treatment of phosphorus) irrespective of the completion of the study and regardless of the assumption of a rescue therapy. addition Intention-to-treat analysis, an analysis will be performed per protocol patients who completed the study. This endpoint is considered to be of utmost clinical importance because it represents the combination of the two possible events that can occur in CKD 3-5. This outcome will be assessed by the investigator and documented in the CRF;Timepoint(s) of evaluation of this end point: 24 months

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Secondary

Measure	Time frame
Secondary end point(s): 1. variations in the parameters of mineral metabolism: phosphorus, fractional excretion of phosphate, PTH, FGF-23 2. annual loss of GFR 3. occurrence of fatal cardiovascular events or otherwise, including those in the AMI, stroke cerebri, coronary revascularization procedures-see Appendix 3) 4. evaluate whether the treatment of hyperphosphatemia reduces or stops the deterioration of the cardiovascular system (progression of vascular calcification by the score of Kauppila;Timepoint(s) of evaluation of this end point: 24 months	—

Measure

Time frame

Secondary end point(s): 1. variations in the parameters of mineral metabolism: phosphorus, fractional excretion of phosphate, PTH, FGF-23 2. annual loss of GFR 3. occurrence of fatal cardiovascular events or otherwise, including those in the AMI, stroke cerebri, coronary revascularization procedures-see Appendix 3) 4. evaluate whether the treatment of hyperphosphatemia reduces or stops the deterioration of the cardiovascular system (progression of vascular calcification by the score of Kauppila;Timepoint(s) of evaluation of this end point: 24 months

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Countries

Italy

Contacts

Public ContactU.O. Nefrologia e Dialisi (Santoro)

AOU di Bologna, Policlinico S.Orsola-Malpighi

antonio.santoro@aosp.bo.it051-6362430

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026