Assessment of Protein Modification in Chronic Kidney Disease - Selected Clinical and Biochemical Aspects

NCT04939870 | Completed

• 1 other identifier: PoznanUMS_DF_1
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

The studies included the effect of chronic kidney disease advancement on the accumulation of oxidative stress markers in plasma. In patients with end-stage renal disease, the effect of replacement therapy was also assessed. Therefore, the patient with chronic kidney disease was evaluated divided into three groups (chronic kidney disease at stage G3b-G4, peritoneal dialysis, hemodialysis). In addition, changes in the interrelationship between oxidative modifications, carbonyl and nitrogen stress, and the carbamylation resulting from the progression of kidney disease have been taken into account. This issue is related to the assessment of whether the protein modification types differentiate patients depending on the stage of chronic kidney disease and the method of renal replacement therapy. Protein modifications associated with oxidative stress are a part of the complications resulting from chronic kidney diseases, such as malnutrition, chronic inflammation, dyslipidemia, iron disorder, and calcium and phosphate disorders. Also, diseases of atherosclerosis aetiology are much higher frequency in patients with chronic kidney disease than in those with normal kidney function. Therefore, in the studies presented here, particular attention was paid to the effect of oxidative stress on chronic kidney disease complications in the aspect of cardiovascular damage. The specificity of atherosclerosis in patients with chronic kidney disease was evaluated by comparing groups of this type of patients with patients with ischemic heart diseases and normal renal function.

Conditions

Chronic Kidney Diseases; Cardiovascular Diseases; Dialysis; Complications

Keywords

oxidative stress, proteins, chronic kidney disease

Outcome Measures

Primary Outcomes (3)

• Biochemical parameters assessed in all groups part 1

  The number of laboratory parameters were determined in all groups: * blood count: HGB \[g/dl\], RBC \[10\*12/l\], HCT \[l/l\], WBC \[10\*9/l\], PLT \[10\*9/l\] * iron metabolism parameters: Fe, UIBC,TIBC \[µg/dl\], ferritin \[ng/ml\] * glucose \[mg/dl\] * parameters of lipid metabolism \[mg/dl\] T-C, LDL-C, HDL-C, TG * parameters of hepatic metabolism \[U/l\]: activity of alanine transaminase, aspartate transaminase, alkaline phosphatase * creatinine \[mg/dl\], uric acid \[mg/dl\], urea \[mg/dl\], * creatinine will be combined with sex \[female/male\] and age \[years\] to report eGFR \[ml/min/1,73m\*2\] calculated on the basis on MDRD formula * albumin \[g/dl\] and total protein \[g/dl\] * Na \[mmol/l\], K \[mmol/l\] * parameters of calcium and phosphate metabolism: total calcium \[mg/dl\], ionised calcium \[mg/dl\], phosphates \[mg/dl\], PTH \[pg/ml\], FGF-23 \[pg/ml\], klotho \[ng/ml\] * selected parameters of inflammation: concentration of highly sensitive C-reactive protein (hsCRP) \[mg/l\]

  4 years

• Biochemical parameters assessed in all groups part 2 - selected parameters of oxidative stress

  CML \[µg/mg protein\], CEL \[µg/mg protein\], MG \[µg/mg protein\], AGE \[µg/mg protein\], RAGE \[µg/mg protein\] 3-NT \[µmol/mg protein\], AOPP \[µmol/mg protein\], carbonyl protein groups \[nmol/mg protein\], carbamyl protein groups \[µg/mg protein\]

  4 years

• Demographic data

  age \[years\], sex \[number of female and male \[n\]\] were recorded in all groups

  4 years

Study Arms (4)

PREDIALYSIS GROUP

(n = 48) - patients in the pre-dialysis period (stage G3b-G4 CKD) with moderate or severe decrease in eGFR (eGFR 44-29 ml / min / 1.73 m2),

Diagnostic Test: Biochemical parameters evaluation

END-STAGE RENAL DISEASE GROUP

patients with ESRD (n=78) - (eGFR \<15 ml/min /1.73 m2) undergoing renal replacement therapy. Depending on the method of renal replacement therapy used, two subgroups are distinguished: PD subgroup (n=35) including patients treated by peritoneal dialysis. In this subgroup, initially, due to the treatment technique, two groups were separated, a group (n=15) treated with the automatic peritoneal dialysis (APD) technique, and a group of patients (n = 20) using the technique of continuous cycling peritoneal dialysis (CCPD), HD subgroup (n = 43) including patients treated with repeated hemodialysis. Hemodialysis procedures were performed in each patient three times a week, via an arteriovenous fistula from own or artificial vessels. The duration of hemodialysis was at least 10 hours/week using standard bicarbonate dialysis fluids and polysulfone low-flux dialyzers. The blood flow during hemodialysis was 200-350 ml/min, with an average dialysis fluid flow of 500 ml/min.

Diagnostic Test: Biochemical parameters evaluation

CARDIOLOGY GROUP

• CARD group (n = 37) - patients with at least one history of cardiovascular events, admitted to hospital for elective angiography, without any signs of impaired kidney function. The studies in this group were to show the changes that occur as a result of diseases of the cardiovascular system and the functioning of the kidneys.

Diagnostic Test: Biochemical parameters evaluation

HEALTHY VOLUNTEERS

Healthy volunteers, (n = 32) - it was composed of healthy people, with no evidence of impairment in renal function and cardiovascular function in the history and at the time of enrollment in the study.

Diagnostic Test: Biochemical parameters evaluation

Interventions

Biochemical parameters evaluation DIAGNOSTIC_TEST

selected biochemical parameters

CARDIOLOGY GROUP; END-STAGE RENAL DISEASE GROUP; HEALTHY VOLUNTEERS; PREDIALYSIS GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study involved 195 people, including 126 patients with diagnosed CKD, under the care of the Nephrology Outpatient Clinic, Peritoneal Dialysis Clinic or the Dialysis Center at the Clinical Hospital. H. Święcicki in Poznań (group from CKD) and 69 people who constituted the control group. Recruitment to the study lasted one year. In the group of patients with CKD, depending on the degree of renal impairment and the type of renal replacement therapy, according to the criteria of diagnosis and classification of CKD according to KDIGO 2012, several subgroups were created. The allocation to groups was based on the GFR, calculated by the recommendations of KDIGO 2012

You may qualify if:

• in group HD:
• a minimum of 6 months of treatment with repeated hemodialysis, 3 times a week, for a minimum of 10 hours a week,
• arteriovenous fistula as a vascular access for hemodialysis,
• Estimated dialysis adequacy ratio (eKt / V) of at least 1.2. in the PD group:
• treatment duration UP to a minimum of 6 months,
• Kt / V ≥1.8 l / week / 1.73 m2.
• For CARD patients, additional conditions include:
• no obvious evidence of renal impairment in the history and at the time of study entry, renal function assessed on the basis of eGFR and urine albumin/creatinine ratio,
• history of angina,
• documented history of at least one acute coronary syndrome,
• admission to the Department of Intensive Care of Cardiology and Internal Diseases in order to perform a planned coronary angiography,
• on the day of admission to the study without signs of acute coronary syndrome,
• no additional comorbidities, ie those that do not result directly or indirectly from coronary heart disease.
• In turn, for the HV group, additional conditions include:
• no obvious evidence of renal impairment in the history and at the time of study entry, renal function assessed on the basis of eGFR and urine albumin/creatinine ratio,

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 60-806, Poland

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dorota Formanowicz, MD,PhD,Prof

  Poznan University of Mediccal Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.Ph.D. Associate Professor

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start: January 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: January 10, 2019
• Last Updated: December 10, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)