NCT03850756

Early Diagnosis of Kidney Damage Associated With Tobacco Use

Completed Last updated 21 March 2025

What this trial tests

trial testing Early kidney damage biomarkers in Kidney Injury in 600 participants. Completed in 1 July 2022.

Timeline

4 March 2019

Primary endpoint
1 April 2022

1 July 2022

Quick facts

Lead sponsor	Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Status	Completed
Study type	OBSERVATIONAL
Enrollment	600
Start date	4 March 2019
Primary completion	1 April 2022
Estimated completion	1 July 2022
Sites	2 locations across Spain

Drugs / interventions tested

• Early kidney damage biomarkers
• Predisposition to kidney injury biomarkers
• Tobacco consumption

Conditions studied

• Kidney Injury — all drugs for Kidney Injury →
• Kidney Disease, Chronic — all drugs for Kidney Disease, Chronic →
• Tobacco Toxicity — all drugs for Tobacco Toxicity →

Sponsor

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León — full company profile →

Who can join

Adults 18 to 99, any sex, with Kidney Injury or Kidney Disease, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Tobacco consumption is associated with the appearance of several pathologies, the best known are Chronic Obstructive Pulmonary Disease, several types of cancer and cardiovascular diseases. However, the association between tobacco and kidney damage is not well defined. Some studies suggest that smoking favors progression to chronic kidney disease (CKD). CKD does not have pharmacological treatment and the only clinical strategies useful so far are dialysis or kidney transplantation. Therefore, knowing if tobacco is involved in this disease is a very relevant fact, since it is a modifiable factor. Of all the risk factors associated with the onset and progression of kidney disease is the only one that can be avoid or eliminated. Therefore quitting smoking could help reduce the incidence of this pathology.

In this project, 3 main objectives were proposed:

1. First: to study the tobacco-CKD association in a more exhaustive way. In a population group (patients who attend a primary care center) the renal function of smokers will be evaluated, comparing it with that of non-smokers with similar characteristics (age, sex, etc). In addition, the presence of certain pathologies that can affect the kidney (diabetes mellitus, hypertension and / or frequent consumption of certain medications) will be taken into account. To evaluate the renal functionality, the markers commonly used in the clinic and other more novel ones will be used (urinary biomarkers of early kidney damage).
2. Second: to assess whether smoking patients will be more likely to suffer kidney damage in the future. This will be done by monitoring the patients mentioned above, for two years. During this time, a group of novel markers (urinary biomarkers of predisposition to kidney damage) that in previous studies have detected susceptibility to kidney damage will be evaluated. It will be determined which one or more of these markers are capable of predicting at time 0 (when the first sample of the patient is taken) the subsequent appearance of renal damage.
3. Third: to study whether stopping smoking reduces the risk of developing CKD. It will be evaluated whether stopping smoking reduces the susceptibility to kidney damage by using the biomarkers mentioned above.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Early Diagnosis of Kidney Damage Associated with Tobacco Use: Preventive Application.
   Tascón J, Prieto M, Casanova AG, Sanz FJ, et al · · 2022 · cited 6× · PMID 35887529 · DOI 10.3390/jpm12071032
2. Designing new diagnostic systems for the early detection of tobacco-associated chronic renal damage in patients of a primary care centre in Salamanca, Spain: an observational, prospective study protocol.
   Prieto M, Vicente-Vicente L, Casanova AG, Hernández-Sánchez MT, et al · · 2020 · cited 1× · PMID 32152160 · DOI 10.1136/bmjopen-2019-032918