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Enrolling by invitationNCT07662889Updated Jun 23, 2026

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

An interventional study of Conventional Hemodialysis and Hemodiafiltration in End-Stage Kidney Disease (ESKD) and Chronic Kidney Disease (CKD), sponsored by Services Institute of Medical Sciences, Pakistan. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by Services Institute of Medical Sciences, Pakistan · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • End-Stage Kidney Disease (ESKD)
  • Chronic Kidney Disease (CKD)

Keywords

  • Hemodiafiltration
  • Conventional Hemodialysis
  • Maintenance Hemodialysis
  • End-Stage Renal Disease
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's planned enrollment of 64 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Services Institute of Medical Sciences, Pakistan is the lead sponsor of 33 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherConventional 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.

  • OtherHemodiafiltration

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and one month after randomization.

Secondary outcomes

  1. 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.

    Time frame: Baseline and one month after randomization.

  2. 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.

    Time frame: Baseline and one month after randomization.

  3. 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.

    Time frame: Baseline and one month after randomization.

  4. 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.

    Time frame: Baseline and one month after randomization.

  5. 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.

    Time frame: Baseline and one month after randomization.

  6. 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.

    Time frame: Baseline and one month after randomization.

  7. 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.

    Time frame: Baseline and one month after randomization.

07

Study locations

1 site
  • Services Institute of Medical Sciences, Lahore
    Lahore, Punjab Province 54000, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07662889
Lead sponsor
Services Institute of Medical Sciences, Pakistan
Responsible party
Rameen Masood (Principal Investigator, Services Institute of Medical Sciences, Pakistan) — Principal investigator
First posted
Jun 23, 2026
Start date
May 23, 2026
Primary completion
Nov 22, 2026 (estimated)
Completion
Nov 22, 2026 (estimated)
Last update
Jun 23, 2026

Study contacts

Zara Ramzan
principal investigator · Services Institute of Medical Sciences, Pakistan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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