Comparing Hemodiafiltration to Conventional Hemodialysis: Effects on Clinical and Biochemical Parameters

A Randomized Clinical Trial Comparing Hemodiafiltration to Conventional Hemodialysis: Effects on Clinical and Biochemical Parameters

Chronic kidney disease may progress to end-stage renal disease, a stage in which the kidneys will no longer be able to adequately remove extra fluid and waste products from the body. Many patients with end-stage renal disease will require regular dialysis to survive. Conventional hemodialysis is the most commonly used dialysis technique and will mainly remove waste products through diffusion. Hemodiafiltration is another dialysis technique that will combine diffusion with convection and may help remove a wider range of waste substances from the blood.

This randomized clinical trial will compare hemodiafiltration with conventional hemodialysis in adult patients with end-stage renal disease who are already receiving maintenance dialysis. Eligible participants will be assigned by random allocation to either conventional hemodialysis or hemodiafiltration. Both treatments will be provided as part of routine dialysis care, and no experimental drug will be used.

The main purpose of the study will be to determine whether hemodiafiltration will lead to better fluid control compared with conventional hemodialysis. Fluid control will be assessed by measuring the average weight gained between dialysis sessions over a four-week period. The study will also compare selected blood test parameters between the two groups after one month, including hemoglobin, C-reactive protein, serum albumin, total cholesterol, serum calcium, serum phosphate, and intact parathyroid hormone.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Kidney Disease (CKD); End-Stage Kidney Disease (ESKD)
• Intervention / Treatment: Other: Conventional Hemodialysis; Other: Hemodiafiltration

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Services Institute of Medical Sciences, Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients aged 18-70 years.
• Both male or female.
• End-stage kidney disease as per operational definition.
• On a stable dialysis prescription for at least 3 months, with thrice-weekly sessions (or unit-standard schedule) and stable dry weight assessment.
• Clinically stable over the preceding 4 weeks, with no hospitalization or acute intercurrent illness.

Exclusion Criteria:

• Cardiovascular instability: recurrent intradialytic hypotension (≥30% of sessions in the prior month requiring saline or early termination), uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg despite therapy), recent acute coronary syndrome, stroke, or decompensated heart failure within 3 months.
• Advanced hepatic disease (decompensated cirrhosis or refractory ascites), active systemic infection, chronic inflammatory disease flare, or active malignancy under treatment likely to confound fluid status or survival.
• Recent blood transfusion within the preceding 4 weeks, or active bleeding, as these may distort hemoglobin and inflammatory indices.
• Advanced chronic liver disease, nephrotic-range protein loss, or other conditions likely to substantially alter serum albumin independent of dialysis modality.
• Parathyroidectomy history or current use of intravenous calcimimetics initiation/change within the preceding 4 weeks, if expected to markedly alter intact parathyroid hormone.
• Adherence concerns: documented inability to follow fluid/salt advice or to attend scheduled treatments during the screening period; anticipated surgery or hospitalization within the study window.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A Conventional Hemodialysis; Participants assigned to this group will receive conventional bicarbonate hemodialysis as per routine departmental dialysis protocol. Each dialysis session will last at least four hours and will be delivered twice or thrice weekly according to unit practice. Other dialysis prescription parameters will be kept as consistent as clinically feasible during follow-up.	Other: Conventional Hemodialysis; Conventional bicarbonate hemodialysis will be performed as part of routine maintenance dialysis care. This technique will primarily remove solutes through diffusion across a semipermeable dialysis membrane, with ultrafiltration for fluid removal.
Experimental: Group B Hemodiafiltration; Participants assigned to this group will receive hemodiafiltration as per routine departmental dialysis protocol. Each dialysis session will last at least four hours and will be delivered twice or thrice weekly according to unit practice. Other dialysis prescription parameters will be kept as consistent as clinically feasible during follow-up.	Other: Hemodiafiltration; Hemodiafiltration will be performed as part of routine maintenance dialysis care. This technique will combine diffusive and convective solute removal, using replacement fluid according to departmental protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Interdialytic Weight Gain	Mean interdialytic weight gain will be assessed in kilograms. For each dialysis session, interdialytic weight gain will be calculated as the pre-dialysis weight of the current session minus the post-dialysis weight of the immediately preceding session. Body weight will be measured using a calibrated digital scale in the dialysis unit. Session-level interdialytic weight gain values will be recorded throughout the follow-up period, and the mean value for each participant will be calculated by dividing the total interdialytic weight gain by the number of attended dialysis sessions.	Baseline and one month after randomization.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Hemoglobin Level	Hemoglobin level will be measured in g/dL using routine hospital laboratory testing. The mean hemoglobin level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.	Baseline and one month after randomization.
Mean C-Reactive Protein Level	C-reactive protein level will be measured in mg/L using routine hospital laboratory testing. The mean C-reactive protein level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.	Baseline and one month after randomization.
Mean Serum Albumin Level	Serum albumin level will be measured in g/dL using routine hospital laboratory testing. The mean serum albumin level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.	Baseline and one month after randomization.
Mean Total Cholesterol Level	Total cholesterol level will be measured in mg/dL using routine hospital laboratory testing. The mean total cholesterol level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.	Baseline and one month after randomization.
Mean Serum Calcium Level	Total serum calcium level will be measured in mg/dL using routine hospital laboratory testing. The mean serum calcium level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.	Baseline and one month after randomization.
Mean Serum Phosphate Level	Serum phosphate level will be measured in mg/dL using routine hospital laboratory testing. The mean serum phosphate level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.	Baseline and one month after randomization.
Mean Intact Parathyroid Hormone Level	Intact parathyroid hormone level will be measured in pg/mL using routine hospital laboratory testing. The mean intact parathyroid hormone level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.	Baseline and one month after randomization.

Collaborators and Investigators

• Sponsor: Services Institute of Medical Sciences, Pakistan
• Investigators: Principal Investigator: Zara Ramzan, Services Institute of Medical Sciences, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2026
• Primary Completion (Estimated): November 22, 2026
• Study Completion (Estimated): November 22, 2026

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Hemodiafiltration; End-Stage Renal Disease; Maintenance Hemodialysis; Conventional Hemodialysis
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Therapeutics; Surgical Procedures, Operative; Sorption Detoxification; Extracorporeal Circulation; Renal Replacement Therapy; Renal Dialysis; Hemofiltration; Hemodiafiltration
• Other Study ID Numbers: ServicesIMSP2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No