Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients

Completed

• Conditions: Chronic Kidney Disease-associated Pruritus

• Registration Number: NCT05524467
• Lead Sponsor: Vifor (International) Inc.

Brief Summary

Vifor International Inc. is seeking real-world evidence (RWE) to better understand the epidemiology, patient characteristics, and management of CKD-aP in the real-world clinical setting.

Detailed Description

This is a non-interventional, cross-sectional, multicentre, and multinational (European) study. The non-interventional study (NIS) design allows the observation of patients in large haemodialysis (HD) centres reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the full discretion of the treating physician without interference by the sponsor or study protocol. All treatment decisions will follow the real-life treatment behaviour.

The CENSUS-EU represents a cross-sectional study design of a representative selection of patients undergoing HD at 113 large dialysis centres across 7 countries in Europe. Prot. v.2.0, 9 May 2023

Study Timeline

• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-09-01
• Study Start: 2023-02-02
• Status Verified: 2023-12
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3100

Inclusion Criteria

• Male or female adult patients with CKD (≥18 years) receiving HD for at least 3 months prior to signing informed consent
• Signed informed consent
• Able and willing to fill in questionnaires

Exclusion Criteria

• Patients performing HD at home or both home and centre

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of CKD-aP in HD patients	A 7-month study timeline	Percentage (%)

Secondary Outcome Measures

Name	Time	Method
The prevalence of CKD-aP by severity	A 7-month study timeline	none, mild, moderate, and severe

Trial Locations

Locations (93)

3011; 🇪🇸 Barcelona, Spain

4005; 🇮🇹 Lecce, Italy

4018; 🇮🇹 Milano, Italy

4021; 🇮🇹 Milano, Italy

4011; 🇮🇹 Modena, Italy

4002; 🇮🇹 Pistoia, Italy

4026; 🇮🇹 Reggio Calabria, Italy

4030; 🇮🇹 Trieste, Italy

4012; 🇮🇹 Verona, Italy

5001; 🇵🇹 Faro, Portugal

5013; 🇵🇹 Gandra, Portugal

5011; 🇵🇹 Gondomar, Portugal

5006; 🇵🇹 Leiria, Portugal

5008; 🇵🇹 Porto, Portugal

5002; 🇵🇹 Sacavém, Portugal

3009; 🇪🇸 Palma De Mallorca, Mallorca, Spain

3005; 🇪🇸 Barcelona, Spain

3006; 🇪🇸 Almería, Spain

3012; 🇪🇸 Barcelona, Spain

3026; 🇪🇸 Barcelona, Spain

3002; 🇪🇸 Benidorm, Spain

7001; 🇬🇧 Leicester, United Kingdom

2009; 🇨🇭 Baden, Switzerland

1043; 🇩🇪 Flensburg, Germany

1046; 🇩🇪 Hanover, Germany

1047; 🇩🇪 Saalfeld/Saale, Germany

1053; 🇩🇪 Sömmerda, Germany

1044; 🇩🇪 Witten, Germany

1051; 🇩🇪 Wuppertal, Germany

4016; 🇮🇹 L'Aquila, Italy

4023; 🇮🇹 Mestre, Italy

4006; 🇮🇹 Pavia, Italy

4014; 🇮🇹 Roma, Italy

4024; 🇮🇹 Rome, Italy

5014; 🇵🇹 Cascais, Portugal

4025; 🇮🇹 Viterbo, Italy

3008; 🇪🇸 Cadiz, Spain

3001; 🇪🇸 Gijón, Spain

3018; 🇪🇸 Granada, Spain

3025; 🇪🇸 Jaen, Spain

3020; 🇪🇸 Las Palmas, Spain

3021; 🇪🇸 León, Spain

3015; 🇪🇸 Madrid, Spain

3016; 🇪🇸 Madrid, Spain

3024; 🇪🇸 Madrid, Spain

3022; 🇪🇸 Madrid, Spain

3017; 🇪🇸 Pamplona, Spain

3013; 🇪🇸 Santander, Spain

3023; 🇪🇸 Sevilla, Spain

3003; 🇪🇸 Valencia, Spain

3004; 🇪🇸 Valencia, Spain

3010; 🇪🇸 Terrassa, Spain

3027; 🇪🇸 Valencia, Spain

6008; 🇸🇪 Linköping, Sweden

6007; 🇸🇪 Malmö, Sweden

6003; 🇸🇪 Trollhättan, Sweden

6001; 🇸🇪 Stockholm, Sweden

6005; 🇸🇪 Norrköping, Sweden

6006; 🇸🇪 Umeå, Sweden

6002; 🇸🇪 Uppsala, Sweden

6004; 🇸🇪 Örebro, Sweden

2001; 🇨🇭 Bern, Switzerland

2002; 🇨🇭 Frauenfeld, Switzerland

2004; 🇨🇭 Lugano, Switzerland

7002; 🇬🇧 Bradford, United Kingdom

7003; 🇬🇧 Hull, United Kingdom

2003; 🇨🇭 Zurich, Switzerland

7005; 🇬🇧 Nottingham, United Kingdom

7004; 🇬🇧 Sheffield, United Kingdom

7006; 🇬🇧 London, United Kingdom

7007; 🇬🇧 London, United Kingdom

3007; 🇪🇸 Sevilla, Spain

4008; 🇮🇹 Macerata, Italy

1111; 🇩🇪 Leipzig, Germany

1013; 🇩🇪 Mainz, Germany

4010; 🇮🇹 Civitavecchia, Italy

4001; 🇮🇹 Firenze, Italy

1113; 🇩🇪 Aschaffenburg, Germany

1007; 🇩🇪 Braunschweig, Germany

1016; 🇩🇪 Einbeck, Germany

1049; 🇩🇪 Freiburg, Germany

1001; 🇩🇪 Herne, Germany

4027; 🇮🇹 Acquaviva Delle Fonti, Italy

4009; 🇮🇹 Monza, Italy

4003; 🇮🇹 Palermo, Italy

1012; 🇩🇪 Eisenach, Germany

1048; 🇩🇪 Freiburg, Germany

1035; 🇩🇪 Kiel, Germany

4015; 🇮🇹 Bari, Italy

4017; 🇮🇹 Parma, Italy

4028; 🇮🇹 Pisa, Italy

4022; 🇮🇹 Treviso, Italy

1011; 🇩🇪 Balingen, Germany