The protective effect of the drug spironolactone on transplanted kidneys

The effect of spironolactone on calcineurin inhibitor induced nephrotoxicity - SPIREN

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002243-98-DK

Enrollment

170

Registered

2011-08-31

Start date

2011-09-12

Completion date

Unknown

Last updated

2021-07-26

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

Conditions

Kidney graft failure MedDRA version: 18.0 Level: PT Classification code 10010185 Term: Complications of transplanted kidney System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: Spirix (spironolakton) Product Name: Spirix Product Code: 3765 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age > 18 years 2. Treated with a calcineurin inhibitor 3. Proteinuria =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. Former intolerance of spironolactone 2. Already treated with spironolactone 3. Resonium or Digoxin treatment 4. Pregnancy or planned pregnancy 5. Clinically relevant organic, systemic or psychological disorder 6. Expectation of non-compliance

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether renal function in kidney transplant patients can be preserved by the addition of spironolactone to standard treatment ;Secondary Objective: 1. Reduction of renal fibrosis – by morphological and molecular biological studies 2. Reduction of protein excretion in urine 3. Reduction of ambulatory bloodpressure 4. Reduction of number of cardiovascular events ;Primary end point(s): Chrome-EDTA clearance;Timepoint(s) of evaluation of this end point: 0, 1, 2 and 3 years	—

Measure

Time frame

Main Objective: To investigate whether renal function in kidney transplant patients can be preserved by the addition of spironolactone to standard treatment ;Secondary Objective: 1. Reduction of renal fibrosis – by morphological and molecular biological studies 2. Reduction of protein excretion in urine 3. Reduction of ambulatory bloodpressure 4. Reduction of number of cardiovascular events ;Primary end point(s): Chrome-EDTA clearance;Timepoint(s) of evaluation of this end point: 0, 1, 2 and 3 years

—

Secondary

Measure	Time frame
Secondary end point(s): • Changes in 24 hour urinary protein excretion • Change in morphological renal fibrosis by microscopy of the kidney biopsy • Changes in renal fibrosis assessed by molecular methods • Changes in systolic and diastolic blood pressure • Change in the number of cardiovascular events ;Timepoint(s) of evaluation of this end point: 0, 1, 2 and 3 years	—

Countries

Denmark

Contacts

Public ContactForskerenheden

Department of nephrology, OUH, Odense, DK

hanne.agerskov@ouh.regionsyddanmark.dk+4565413259

Outcome results

None listed

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