Condition category
Circulatory System
Date applied
17/12/2012
Date assigned
23/01/2013
Last edited
23/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Ischemia and reperfusion processes are the major causes of acute kidney injury in patients receiving real tissues from a donor (this is called a renal allograft). This leads to different degrees of early post-transplant renal dysfunction. Aldosterone is a traditional treatment but has disadvantages. The aim of the study is to assess whether giving another drug called Spironolactone before and after renal transplant rom living donors decreases renal damage caused by ischemia/reperfusion

Who can participate?
You may participate if you are a patient in hemodialysis or peritoneal dialysis and you will receive a renal allograft from a living donor, you are at least 18 years old, you are male or female, you are compatible with your donor
You cannot enter this study if you receive two or more organs simultaneously and if you receive allograft from a deceased donor.

What does the study involve?
Participants will be randomly allocated to one of three groups of treatment (Spironolactone 50 mg, Spironolactone 100 mg or dummy). All treatments looks identical (1 capsule). Neither you nor your doctors will be able to know or decide which group you are in. You will take the capsule twice a day, three days before transplant surgery and five days after your surgery. The doctors will ask your permission to get a sample of blood and urine before transplant surgery and at days 1, 5 after transplant. They will use the samples to carry out routine laboratory tests in the laboratory that may help them to compare renal function recovery and biomarkers of renal injury. At day five after your surgery your participation will be completed.

What are the possible benefits and risks of participating?
The most common side effect of spironolactone is hyperkalemia (high level of serum potassium).

Where is the study run from?
This study will recruit 60 patients a year from the Transplant Department at Instituto Nacional de Ciencias Médicas Salvador Zubiran in México City, Hospital General de Mexico and
Centro Médico Nacional Siglo XXI.

When is the study starting and how long is it expected to run for?
From January 2013 to .May 2014.

Who is funding the study?
Mexican Council of Science and Technology and National University of Mexico grants.

Who is the main contact?
Dr Luis E. Morales-Buenrostro
Dr Norma A. Bobadilla, norma.bobadillas@quetzal.innsz.mx

Trial website

Contact information

Type

Scientific

Primary contact

Dr Norma A Bobadilla

ORCID ID

Contact details

Vasco de Quiroga no.
15 Col. Sección XVI
D.F
14000
Mexico
+52 (0) 555 5485-2676
norma.bobadillas@quetzal.innsz.mx

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

REF 421

Study information

Scientific title

Effect of mineralocorticoid receptor blockade on ischemia / reperfusion injury in renal transplant recipients: A pilot study

Acronym

Study hypothesis

Spironolactone reduces the tubular damage and oxidative stress in renal transplant patients from living donor.

Ethics approval

Ethical Committee of National Institute of Medical Sciences and Nutrition (Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran), January 2012, Ref 421

Study design

Double-blind randomized placebo-controlled clinical pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Ischemia reperfusion injury

Intervention

The patients will be randomized to receive 50 or 100 mg of spironolactone (Sp) or placebo orally twice daily (BID), 3 days prior to transplant surgery and 50 or 100 mg of Sp or placebo orally BID during three consecutive days after transplantation.

Intervention type

Drug

Phase

Not Applicable

Drug names

Spironolactone

Primary outcome measures

Reduction of urinary biomarkers of kidney injury [ Heat shock protein 72 (HsP72), Interleukin-18 (IL-18), kidney injury molecule-1 (KIM-1)] at baseline, day 1, and 5 post transplantation.

Secondary outcome measures

1. Reduction of oxidative stress
2. Change in urinary hydrogen peroxide excretion
3. Change in urinary nitrates excretion

All measures at baseline, day 1, and 5 post transplantation

Overall trial start date

01/01/2013

Overall trial end date

01/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age of 18 years or older, male and female
2. Receipt of a live-donor kidney

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Multi-organ transplant
2. Deceased-donor kidney
3. Induction with thymoglobuline

Recruitment start date

01/01/2013

Recruitment end date

01/05/2014

Locations

Countries of recruitment

Mexico

Trial participating centre

Vasco de Quiroga no.
D.F
14000
Mexico

Sponsor information

Organisation

Mexican Council of Science and Technology (Consejo Nacional de Ciencia y Tecnología CONACyT) (Mexico)

Sponsor details

Av. Insurgentes Sur 1582
Col. Crédito Constructor Del.
Benito Juárez C.P.: 03940
Mexico DF
-
Mexico
+52 (0) 555 5322-7700
carcer@conacyt.mx

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Sector Grant from Mexican Council of Science and Technology (Fondo Sectorial Salud 2012) (Mexico) Project: SALUD-2012-01-181267

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes