NCT03239808: IHDIP

Incremental Haemodialysis in Incident Patients

Active, enrolled NA Last updated 5 March 2025

What this trial tests

NA trial testing Incremental haemodialysis in Renal Disease, End-Stage in 152 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

14 March 2018

Primary endpoint
6 June 2024

30 June 2025

Quick facts

Lead sponsor	Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	152
Start date	14 March 2018
Primary completion	6 June 2024
Estimated completion	30 June 2025
Sites	3 locations across Spain

Drugs / interventions tested

• Incremental haemodialysis
• Conventional haemodialysis

Conditions studied

• Renal Disease, End-Stage — all drugs for Renal Disease, End-Stage →

Sponsor

Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura

Who can join

18 and older, any sex, with Renal Disease, End-Stage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Incremental hemodialysis (HD) is a starting regime for renal replacement therapy (RRT) adapted to each patient's necessities. It is mainly conditioned by the residual renal function (RRF). The frequency of sessions with which patients start HD -one or two sessions per week-, is lower than that for conventional HD three times per week. Such frequency is increased (from one to two sessions, and from two to three sessions) as the RRF declines.

Methods/Design: IHDIP is a multicenter randomized experimental open trial. It is randomized in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level and non-commercial. It includes 152 patients older than 18 years with chronic renal disease stage 5 and start HD as RRT, with a RRF of ≥ 4ml/min/1.73m2, measured by renal clearance of urea (KrU). The intervention group includes 76 patients who will start with one session of HD per week (incremental HD). The control group includes 76 patients who will start with three sessions per week (conventional HD). The primary purpose is assessing the survival rate, while the secondary purposes are the morbidity rate (hospital admissions), the clinical parameters, the quality of life and the efficiency.

Discussion: This study will enable us to know with the highest level of scientific evidence, the number of sessions a patient should receive when starting the HD treatment, depending on his/her RRF.

Publications & conference data

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

1. Narrative Review of Incremental Hemodialysis.
   Murea M, Moossavi S, Garneata L, Kalantar-Zadeh K. · · 2020 · cited 38× · PMID 32043027 · DOI 10.1016/j.ekir.2019.11.014
2. A clinical trials corpus annotated with UMLS entities to enhance the access to evidence-based medicine.
   Campillos-Llanos L, Valverde-Mateos A, Capllonch-Carrión A, Moreno-Sandoval A. · · 2021 · cited 31× · PMID 33618727 · DOI 10.1186/s12911-021-01395-z
3. IHDIP: a controlled randomized trial to assess the security and effectiveness of the incremental hemodialysis in incident patients.
   Deira J, Suárez MA, López F, García-Cabrera E, et al · · 2019 · cited 30× · PMID 30626347 · DOI 10.1186/s12882-018-1189-6
4. Incremental dialysis: two complementary views.
   Casino DFG, Murea M, Floege MJ, Zoccali C. · · 2024 · cited 7× · PMID 38404364 · DOI 10.1093/ckj/sfae020
5. Rationale and design of DiPPI: A randomized controlled trial to evaluate the safety and effectiveness of progressive hemodialysis in incident patients.
   Suárez MA, García-Cabrera E, Gascón A, López F, et al · · 2018 · cited 2× · PMID 30344012 · DOI 10.1016/j.nefro.2018.07.010
6. Nutritional Ultrasound in the Morphofunctional Assessment of Malnutrition in Patients Undergoing Incremental Versus Conventional Hemodialysis: A Comparative Study.
   Jiménez Mayor E, De La Flor JC, Chandu Nanwani A, Rodríguez Tudero C, et al · · 2025 · cited 1× · PMID 41011024 · DOI 10.3390/medicina61091633
7. Incremental versus standard dialysis for people with kidney failure
   Sabanayagam D, Hegerty K, Au E, Beruni N, et al · · 2023