NCT01602861

Brief Summary

The purpose of this study is to assess whether the diuretic drug spironolactone can prevent chronic damage to transplanted kidneys caused by the medication that prevents rejection. Spironolactone prevents the effects of the hormone aldosterone. Aldosterone is suspected of being involved in the processes leading to chronic rejection of transplanted kidneys. Hence, by blocking the effects of aldosterone we hope to be able to prevent loss of kidney function in transplant patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

8.2 years

First QC Date

May 17, 2012

Last Update Submit

September 8, 2021

Conditions

Disorder Related to Renal Transplantation

Keywords

Fibrosiscalcineurin inhibitorkidney transplantchronic rejection

Outcome Measures

Primary Outcomes (1)

  • Change in Cr EDTA clearance

    0, 1 year, 2 years, 3 years

Secondary Outcomes (4)

  • Reduced urine protein levels (change from baseline)

    0, 1 year, 2 years, 3 years

  • Reduced fibrosis (change from baseline)

    0, 2 years

  • Reduced blood pressure (change from baseline)

    0, 1 year, 2 years, 3 years

  • Cardiovascular events

    3 years

Study Arms (2)

Spironolactone

EXPERIMENTAL
Drug: Spironolactone

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

SpironolactoneDRUG

One tablet per day (25 mg Spironolactone/placebo) for the first three months. Subsequently dosage is increased to two tablets per day (50 mg Spironolactone/placebo) for the rest of the study. In case of hyperkaliemia (\>5,5 mmol/L) or intolerable side effects dosage will be reduced to one tablet per day (25 mg Spironolactone/placebo).

Spironolactone
placeboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Proteinuria \< 3 g/24 hours
  • Creatinine clearance ≥ 30 mL/min
  • S-Potassium \< 5,5 mmol/L

You may not qualify if:

  • Intolerance to spironolactone
  • Creatinine clearance \< 30 ml/min
  • S-Potassium ≥ 5,5 mmol/L
  • Resin or digoxine treatment
  • Pregnancy or planned pregnancy
  • Relevant organic, systemic or mental illness
  • Anticipation of lack of compliance or understanding the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

Location

Related Publications (2)

  • Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.

    PMID: 39082471DERIVED

  • Mortensen LA, Thiesson HC, Tougaard B, Egfjord M, Fischer ASL, Bistrup C. The effect of spironolactone on calcineurin inhibitor induced nephrotoxicity: a multicenter randomized, double-blind, clinical trial (the SPIREN trial). BMC Nephrol. 2018 May 3;19(1):105. doi: 10.1186/s12882-018-0885-6.

    PMID: 29724188DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Claus Bistrup, MD, ph.d.

    Dep. of Nephrology, Odense University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2012

First Posted

May 21, 2012

Study Start

February 1, 2013

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

DK(1)