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A single center study to evaluate the safety and tolerability of oral Azathioprine in patients with ADPKD

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524313-86-00
Enrollment
40
Registered
2026-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-21

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

Conditions

Autosomal dominant polycystic kidney and liver disease

Brief summary

% of treatment stop due to leucopenia, % of treatment stop due to liver function distrubances, % of treatment stop due to subjective intolerance of treatment, Number of infections, Patient-reported outcome measures (PROs): Validated questionnaires to assess quality of life (QoL) and symptom burden (e.g. abdominal discomfort, fatigue, physical limitation) will be completed at baseline, week 8, week 32, week 56 and week 60.

Detailed description

Log-transformed annualised relative change of height adjusted total kidney volume (htTKV) and ht total liver volume (htTLV) (%/year) from baseline to week 56 of treatment, Change in eGFR from baseline eGFR to week 52 of treatment

Interventions

DRUGAzathioprine 25 mg film-coated tablets

Sponsors

UZ Leuven
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
% of treatment stop due to leucopenia, % of treatment stop due to liver function distrubances, % of treatment stop due to subjective intolerance of treatment, Number of infections, Patient-reported outcome measures (PROs): Validated questionnaires to assess quality of life (QoL) and symptom burden (e.g. abdominal discomfort, fatigue, physical limitation) will be completed at baseline, week 8, week 32, week 56 and week 60.

Secondary

MeasureTime frame
Log-transformed annualised relative change of height adjusted total kidney volume (htTKV) and ht total liver volume (htTLV) (%/year) from baseline to week 56 of treatment, Change in eGFR from baseline eGFR to week 52 of treatment

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 22, 2026