Chronic Kidney DiseaseINSPiRENCT07338435
"Residual Kidney Function and Oxidative Stress in Incremental vs Standard Peritoneal Dialysis (2 Mexican Centers)"
A study testing Standard Peritoneal Dialysis and Incremental Peritonal Dialysis in people with Chronic Kidney Disease and Diabetic Kidney Disease, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Title: Comparison of Oxidative Stress and Preservation of Residual Kidney Function Between Incremental and Standard Peritoneal Dialysis in Incident Patients at the Regional General Hospital No. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease, Diabetic Kidney Disease, Peritoneal Dialysis (PD)
- What is being tested?
- Standard Peritoneal Dialysis and Incremental Peritonal Dialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 1 Nov 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD adults starting on PD FKR ≥2 mL/min Urine Volumen ≥500 mL/24 hrs Type 2 Diabetes, Hypertension and unknown cause of CKD
Who cannot join
- Self-reported smoking or active use of illicit drugs. Patients with liver disease. Patients with glomerulonephritis. Patients with a history of previous renal replacement therapy (hemodialysis or kidney transplant).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Comparison of Preservation Residual Renal Function and Oxidative Damage Between Incremental and Standard Peritoneal Dialysis in Incident Patients at Two Centers of Mexico.
Title:
Comparison of Oxidative Stress and Preservation of Residual Kidney Function Between Incremental and Standard Peritoneal Dialysis in Incident Patients at the Regional General Hospital No. 58 and HGZ/UMF 21 of the Mexican Institute of Social Security (IMSS) in León, Guanajuato
Read more
BACKGROUND:
Peritoneal dialysis (PD) employs hypertonic dextrose-based solutions to remove toxins and excess fluids. This exposure promotes mitochondrial overproduction of reactive oxygen species (ROS), triggers inflammation, and may accelerate the decline of residual kidney function (RKF), leading to complications such as peritonitis, peritoneal fibrosis, and technique failure. Although more biocompatible solutions are available, their high cost and limited accessibility restrict their use in our setting.
Incremental peritoneal dialysis (IPD), in contrast to standard peritoneal dialysis (SPD)-which typically involves four daily exchanges with full-dose dialysis-uses reduced dialysis doses tailored to RKF, thereby decreasing glucose exposure.
The primary aim of this study was to compare the effects of IPD versus SPD on oxidative stress, inflammation, and the preservation of residual kidney function in incident peritoneal dialysis patients at the Regional General Hospital No. 58 in León, Guanajuato.
MATERIALS AND METHODS:
A prospective, longitudinal, single-center, open-label, randomized clinical trial will be conducted. Incident peritoneal dialysis patients at the Regional General Hospital No. 58 and Gneral Hospital of Zone Numbre 21 of the Mexican Institute of Social Security (IMSS) who meet the inclusion criteria and provide informed consent will be randomly assigned to either the standard or incremental peritoneal dialysis group.
Acute-phase reactants will be measured at baseline and at 3, 6, 9, and 12 months. Oxidative stress will be assessed via baseline and end-of-study malondialdehyde levels. Dialysis and urine Kt/V will be evaluated betwen 6 weeks and 3 moths and 6, 9, and 12 months. Appropriate statistical analyses will be performed thereafter.
Read the detailed description
Eligible incident peritoneal dialysis (PD) patients from two IMSS hospitals in León, Guanajuato (HGR No. 58 and HGZ-MF No. 21) will be enrolled after confirmation of adequate Tenckhoff catheter placement and written informed consent. Baseline demographic and clinical data will be collected from medical records and physical examination, including age, sex, marital status, educational level, anthropometric parameters (weight, height, body mass index), and volume status assessed by physical examination using the Godet edema scale.
Laboratory evaluations will be performed in blood and urine. Fasting venous blood samples will be obtained for complete blood count, serum chemistry, electrolytes, lipid profile, inflammatory markers (albumin, ferritin, C-reactive protein, D-dimer), and viral serology (HBV, HCV, HIV). Oxidative stress will be assessed in serum by measuring thiobarbituric acid-reactive substances (TBARS) as an index of malondialdehyde concentration using a standardized spectrophotometric method.
Residual renal function will be assessed at baseline and during follow-up (45 days, and 3, 6, 9, and 12 months) by estimated glomerular filtration rate (CKD-EPI equation), 24-hour urine volume, and 24-hour creatinine clearance. Solute clearance adequacy (renal and peritoneal Kt/V) will be measured at 1.5-3 months, 6 months, and 12 months. Peritoneal membrane transport characteristics will be evaluated at month 3 using the Peritoneal Equilibration Test (PET).
Participants will be randomized in a 1:1 ratio to Incremental Peritoneal Dialysis or Standard Peritoneal Dialysis using block randomization (blocks of four). Glucose exposure will be quantified based on dialysate glucose concentration and number of exchanges, expressed as bags per year. Catheter-related complications and infection-free catheter survival will be monitored throughout the 12-month follow-up. After completion of follow-up, patients will continue PD according to their treating nephrologist's prescription.
- Conditions
- Chronic Kidney Disease, Diabetic Kidney Disease, Peritoneal Dialysis (PD), Hypertension, Hypertension With Renal Dysfunction
- Being tested
- Standard Peritoneal Dialysis, Incremental Peritonal Dialysis
- Keywords
- inflammation., chronic kidney disease., oxidative stress, malondialdehyde, residual kidney function, incremental peritoneal dialysis, peritoneal dialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetic Nephropathies, Hypertension, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Peritoneal DialysisProcedure or surgery
Also called DPCA
4 exchanges with nocturnal dwell.
Incremental Peritonal DialysisProcedure or surgery
Also called IPD
lower dialysis doses based on RKF, generally 3 exchanges or less.
| Study group | Role | What they receive |
|---|---|---|
| Incremental peritoneal dialysis (IPD) | Experimental | uses reduced dialysis doses less exchanges, generally 3 or less Receives: Procedure: Incremental Peritonal Dialysis |
| Standard peritoneal dialysis (SPD) | Active comparator | standard peritoneal dialysis (SPD)-which typically involves four daily exchanges of 4-5 hours each one with night exchange, known too like full-dose dialysis Receives: Procedure: Standard Peritoneal Dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress Serum malondialdehyde (MDA) levels
Oxidative stress will be assessed by serum malondialdehyde (MDA) concentration measured as thiobarbituric acid-reactive substances (TBARS) using spectrophotometry at 532 nm. Results will be expressed in nmol/mL.
Measured: Baseline and 12 months
Residual kidney function
Residual kidney function will be evaluated by estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI equation (mL/min/1.73 m²), 24-hour, 24-hour urine volume (liters), and 24-hour creatinine clearance (mL/min).
Measured: Baseline, 45 days, 3 months, 6 months, 9 months, and 12 months
Secondary outcomes (2)
Systemic inflammation: Inflammatory biomarkers
Systemic inflammation will be assessed by serum levels of C-reactive protein (CRP, mg/L), ferritin (ng/mL), albumin (g/dL), and D-dimer (ng/mL), measured using standardized laboratory methods.
Measured: at 3, 6,9, and 12 moths
Catheter-related outcomes
Catheter outcomes will be assessed by time to first catheter-related complication or infection, expressed as complication-free catheter survival.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Nov 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The researchers will assign the participants by lottery using a table of numbers to each of the incremental or standard dialysis treatments, forming groups A and B. To form the treatment groups, the options will be A: Incremental peritoneal dialysis (IPD) and B: Standard peritoneal dialysis (standard PD or CAPD). A probabilistic number will be determined using block randomization, so the group will be divided into 10 blocks of 4 patients each, assigning 2 to group A and 2 to group B.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Collaborators
- Universidad de Guanajuato
- Responsible party
- Principal investigator, Veronica Valdivia Cerda, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338435
- Sponsor's protocol ID
- R-2024-1009-44
- Acronym
- INSPiRE
- Status last verified
- Jan 2026
- First submitted
- 25 Nov 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Database and Informed consent
Publications
Basso A, Baldini P, Bertoldi G, Driussi G, Caputo I, Bettin E, Cacciapuoti M, Calo LA. Oxidative stress reduction by icodextrin-based glucose-free solutions in peritoneal dialysis: Support for new promising approaches. Artif Organs. 2024 Sep;48(9):1031-1037. doi: 10.1111/aor.14801. Epub 2024 Jun 1.
PubMed 38822597Kunin M, Beckerman P. The Peritoneal Membrane-A Potential Mediator of Fibrosis and Inflammation among Heart Failure Patients on Peritoneal Dialysis. Membranes (Basel). 2022 Mar 11;12(3):318. doi: 10.3390/membranes12030318.
PubMed 35323792Blake PG, Dong J, Davies SJ. Incremental peritoneal dialysis. Perit Dial Int. 2020 May;40(3):320-326. doi: 10.1177/0896860819895362. Epub 2020 Jan 17.
PubMed 32063212
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparison of Preservation Residual Renal Function and Oxidative Damage Between Incremental and Standard Peritoneal Dialysis in Incident Patients at Two Centers of Mexico.
- ClinicalTrials.gov ID
- NCT07338435
- Acronym / sponsor ID
- INSPiRE / R-2024-1009-44
- Conditions
- Chronic Kidney Disease, Diabetic Kidney Disease, Peritoneal Dialysis (PD), Hypertension, Hypertension With Renal Dysfunction
- Keywords
- inflammation., chronic kidney disease., oxidative stress, malondialdehyde, residual kidney function, incremental peritoneal dialysis, peritoneal dialysis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Collaborators
- Universidad de Guanajuato
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title:
Comparison of Oxidative Stress and Preservation of Residual Kidney Function Between Incremental and Standard Peritoneal Dialysis in Incident Patients at the Regional General Hospital No. 58 and HGZ/UMF 21 of the Mexican Institute of Social Security (IMSS) in León, Guanajuato
BACKGROUND:
Peritoneal dialysis (PD) employs hypertonic dextrose-based solutions to remove toxins and excess fluids. This exposure promotes mitochondrial overproduction of reactive oxygen species (ROS), triggers inflammation, and may accelerate the decline of residual kidney function (RKF), leading to complications such as peritonitis, peritoneal fibrosis, and technique failure. Although more biocompatible solutions are available, their high cost and limited accessibility restrict their use in our setting.
Incremental peritoneal dialysis (IPD), in contrast to standard peritoneal dialysis (SPD)-which typically involves four daily exchanges with full-dose dialysis-uses reduced dialysis doses tailored to RKF, thereby decreasing glucose exposure.
The primary aim of this study was to compare the effects of IPD versus SPD on oxidative stress, inflammation, and the preservation of residual kidney function in incident peritoneal dialysis patients at the Regional General Hospital No. 58 in León, Guanajuato.
MATERIALS AND METHODS:
A prospective, longitudinal, single-center, open-label, randomized clinical trial will be conducted. Incident peritoneal dialysis patients at the Regional General Hospital No. 58 and Gneral Hospital of Zone Numbre 21 of the Mexican Institute of Social Security (IMSS) who meet the inclusion criteria and provide informed consent will be randomly assigned to either the standard or incremental peritoneal dialysis group.
Acute-phase reactants will be measured at baseline and at 3, 6, 9, and 12 months. Oxidative stress will be assessed via baseline and end-of-study malondialdehyde levels. Dialysis and urine Kt/V will be evaluated betwen 6 weeks and 3 moths and 6, 9, and 12 months. Appropriate statistical analyses will be performed thereafter.
Detailed description
Eligible incident peritoneal dialysis (PD) patients from two IMSS hospitals in León, Guanajuato (HGR No. 58 and HGZ-MF No. 21) will be enrolled after confirmation of adequate Tenckhoff catheter placement and written informed consent. Baseline demographic and clinical data will be collected from medical records and physical examination, including age, sex, marital status, educational level, anthropometric parameters (weight, height, body mass index), and volume status assessed by physical examination using the Godet edema scale.
Laboratory evaluations will be performed in blood and urine. Fasting venous blood samples will be obtained for complete blood count, serum chemistry, electrolytes, lipid profile, inflammatory markers (albumin, ferritin, C-reactive protein, D-dimer), and viral serology (HBV, HCV, HIV). Oxidative stress will be assessed in serum by measuring thiobarbituric acid-reactive substances (TBARS) as an index of malondialdehyde concentration using a standardized spectrophotometric method.
Residual renal function will be assessed at baseline and during follow-up (45 days, and 3, 6, 9, and 12 months) by estimated glomerular filtration rate (CKD-EPI equation), 24-hour urine volume, and 24-hour creatinine clearance. Solute clearance adequacy (renal and peritoneal Kt/V) will be measured at 1.5-3 months, 6 months, and 12 months. Peritoneal membrane transport characteristics will be evaluated at month 3 using the Peritoneal Equilibration Test (PET).
Participants will be randomized in a 1:1 ratio to Incremental Peritoneal Dialysis or Standard Peritoneal Dialysis using block randomization (blocks of four). Glucose exposure will be quantified based on dialysate glucose concentration and number of exchanges, expressed as bags per year. Catheter-related complications and infection-free catheter survival will be monitored throughout the 12-month follow-up. After completion of follow-up, patients will continue PD according to their treating nephrologist's prescription.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The researchers will assign the participants by lottery using a table of numbers to each of the incremental or standard dialysis treatments, forming groups A and B. To form the treatment groups, the options will be A: Incremental peritoneal dialysis (IPD) and B: Standard peritoneal dialysis (standard PD or CAPD). A probabilistic number will be determined using block randomization, so the group will be divided into 10 blocks of 4 patients each, assigning 2 to group A and 2 to group B.
| Arm | Type | Receives |
|---|---|---|
| Incremental peritoneal dialysis (IPD) | Experimental | Procedure: Incremental Peritonal Dialysisuses reduced dialysis doses less exchanges, generally 3 or less |
| Standard peritoneal dialysis (SPD) | Active comparator | Procedure: Standard Peritoneal Dialysisstandard peritoneal dialysis (SPD)-which typically involves four daily exchanges of 4-5 hours each one with night exchange, known too like full-dose dialysis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CKD adults starting on PD FKR ≥2 mL/min Urine Volumen ≥500 mL/24 hrs Type 2 Diabetes, Hypertension and unknown cause of CKD
Key exclusion criteria (1 listed)
- Self-reported smoking or active use of illicit drugs. Patients with liver disease. Patients with glomerulonephritis. Patients with a history of previous renal replacement therapy (hemodialysis or kidney transplant).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Peritoneal DialysisAlso: DPCA4 exchanges with nocturnal dwell. | Procedure or surgery | Standard peritoneal dialysis (SPD) |
| Incremental Peritonal DialysisAlso: IPDlower dialysis doses based on RKF, generally 3 exchanges or less. | Procedure or surgery | Incremental peritoneal dialysis (IPD) |
Primary outcome
Oxidative stress Serum malondialdehyde (MDA) levels
Time frame: Baseline and 12 months
Oxidative stress will be assessed by serum malondialdehyde (MDA) concentration measured as thiobarbituric acid-reactive substances (TBARS) using spectrophotometry at 532 nm. Results will be expressed in nmol/mL.
Residual kidney function
Time frame: Baseline, 45 days, 3 months, 6 months, 9 months, and 12 months
Residual kidney function will be evaluated by estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI equation (mL/min/1.73 m²), 24-hour, 24-hour urine volume (liters), and 24-hour creatinine clearance (mL/min).
2 secondary outcomes
Systemic inflammation: Inflammatory biomarkers
Time frame: at 3, 6,9, and 12 moths
Catheter-related outcomes
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 38822597Basso A, Baldini P, Bertoldi G, Driussi G, Caputo I, Bettin E, Cacciapuoti M, Calo LA. Oxidative stress reduction by icodextrin-based glucose-free solutions in peritoneal dialysis: Support for new promising approaches. Artif Organs. 2024 Sep;48(9):1031-1037. doi: 10.1111/aor.14801. Epub 2024 Jun 1.
- Background: PubMed 35323792Kunin M, Beckerman P. The Peritoneal Membrane-A Potential Mediator of Fibrosis and Inflammation among Heart Failure Patients on Peritoneal Dialysis. Membranes (Basel). 2022 Mar 11;12(3):318. doi: 10.3390/membranes12030318.
- Background: PubMed 32063212Blake PG, Dong J, Davies SJ. Incremental peritoneal dialysis. Perit Dial Int. 2020 May;40(3):320-326. doi: 10.1177/0896860819895362. Epub 2020 Jan 17.
- Individual participant dataSharing planned: Yes. Database and Informed consent
Related trials for Chronic Kidney Disease
RecruitingObservational study
Immune System Related Kidney Disease
Kidney Disease, Nephrotic Syndrome
Recruiting
Diuretic Tuner Clinical Decision Support
Edema, Hypervolemia
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD)
Chronic Kidney Diseases
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Peritoneal Dialysis and Incremental Peritonal Dialysis in people with Chronic Kidney Disease and Diabetic Kidney Disease, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative stress Serum malondialdehyde (MDA) levels (time frame: Baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07338435, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.