A prospective, non-interventional study to evaluate use of Kinpeygo® in patients with IgA Nephropathy under real-world conditions Non-interventional Analysis and Verification of IgA Nephropathy Therapy Endpoints - The “navIgAte” Study

A prospective, non-interventional study to evaluate use of Kinpeygo® in patients with IgA Nephropathy under real-world conditions Non-interventional Analysis and Verification of IgA Nephropathy Therapy Endpoints - The “navIgAte” Study - navIgAte

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040176

Enrollment

150

Registered

2026-05-19

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

IgA-Nephropathy

Interventions

Group 1: Patients with IgA nephropathy (IgAN) for whom treatment with Kinpeygo®, independent of study participation, has been decided, will be prospectively observed over an observation period of up t

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Kinpeygo® treatment indicated (physician decision independent of study) 2. =18 years with primary IgA nephropathy (IgAN) 3. Able and willing to complete questionnaires 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to Kinpeygo® or excipients 2. Severe hepatic impairment (Child-Pugh C) 3. Current participation in another clinical study 4. Kinpeygo® treatment within 3 months prior to inclusion

Design outcomes

Primary

Measure	Time frame
Descriptive assessment of clinical decision-making patterns at Kinpeygo® initiation in IgAN patients (V1), including physician-reported rationale for prescription (e.g., classification of parameters like proteinuria, eGFR as immune- vs. CKD-indicators), patient characteristics, and changes in routine lab parameters from baseline (V1) to FU3 (18 months). Data from eCRF (physician questionnaire), medical charts, and routine labs.	—

Measure

Time frame

Descriptive assessment of clinical decision-making patterns at Kinpeygo® initiation in IgAN patients (V1), including physician-reported rationale for prescription (e.g., classification of parameters like proteinuria, eGFR as immune- vs. CKD-indicators), patient characteristics, and changes in routine lab parameters from baseline (V1) to FU3 (18 months). Data from eCRF (physician questionnaire), medical charts, and routine labs.

—

Secondary

Measure	Time frame
Descriptive assessment of implementation of updated KDIGO guidelines (2025), applied therapeutic strategies (pharmacological/supportive beyond Kinpeygo®), and patient perceptions on quality of life, disease burden, and disease understanding via patient questionnaire (V1, V4, FU3). Data from eCRF, routine medical charts/labs, and study-specific patient questionnaire (~15 min).	—

Countries

Germany

Contacts

Public ContactJörg Latus

Robert-Bosch-Krankenhaus

Joerg.Latus@rbk.de+49 711 8101-3496

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026