The protective effect of the drug spironolactone on transplanted kidneys

Phase 1

• Conditions: Kidney graft failure; MedDRA version: 18.0Level: PTClassification code 10010185Term: Complications of transplanted kidneySystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-002243-98-DK
• Lead Sponsor: Department of Nephrology, OUH, Odense, DK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-31
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1. Age > 18 years
2. Treated with a calcineurin inhibitor
3. Proteinuria < 3 g/day
4. Creatinine clearance = 30 mL/min
5. Plasma potassium < 5.5 mmol/L
6. Negative pregnancy test at inclusion for women of childbearing potential and adequate contraception throughout the trial

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified