Renal Disease, End-Stage Clinical Trial
— IHDIPOfficial title:
Assessment of the Incremental Haemodialysis Security and Effectiveness in Incident Patients
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.
Status | Active, not recruiting |
Enrollment | 152 |
Est. completion date | September 6, 2024 |
Est. primary completion date | June 6, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults aged >18 years, incident patients with stage 5 CKD who have chosen HD as RRT initiation. - RRF measured by KrU = 4 ml/min/1.73m2. In general, it is advised not to start HD with a KrU> 7. - Informed consent signed before starting any activity related to the trial. Exclusion Criteria: - Unplanned HD initiation (established in point 7.4 of the protocol) - Non incident patients, in other words, patients who were previously on RRT, either on peritoneal dialysis, or on kidney transplant. - Active neoplasia at the moment of inclusion - Cardiovascular disease defined as: heart failure type IV of the New York Heart Association (NYHA), unstable angina or ischemic cardiopathy which has caused any admission in hospital in the last 3 months. - Cardiorenal syndrome - Active inflammatory disease with immunosuppressive treatment - Hepatorenal syndrome |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital San Pedro de Alcántara | Cáceres | |
Spain | FundeSalud. Junta de Extremadura | Mérida | Badajoz |
Spain | Hospital Virgen del Puerto | Plasencia | Cáceres |
Lead Sponsor | Collaborator |
---|---|
Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura | Dialysis Center SM2. Potenza (Italy), Hospital Arquitecto Marcide. Ferrol. A Coruña. (Spain), Hospital Central de la Defensa Gómez Ulla. Madrid (Spain), Hospital Costa del Sol, Hospital de Especialidades de las Fuerzas Armadas. Quito (Ecuador), Hospital de Manises. Valencia (Spain), Hospital del Río Hortega, Hospital del SAS de Jerez, Hospital Duran de Buenos Aires, Hospital El Bierzo, Hospital Nuestra Sra de Sonsoles. Ávila (Spain), Hospital Obispo Polanco. Teruel (Spain), Hospital San Pedro de Alcantara, Hospital Universitario Dr J Trueta, Hospital Universitario Virgen Macarena, Hospital Virgen de la Concha. Zamora (Spain), Hospitales Universitarios Virgen del Rocío, Miulli General Hospital, Servicio Extremeño de Salud (Spain), Virgen del Puerto Hospital |
Spain,
Bolasco P, Cupisti A, Locatelli F, Caria S, Kalantar-Zadeh K. Dietary Management of Incremental Transition to Dialysis Therapy: Once-Weekly Hemodialysis Combined With Low-Protein Diet. J Ren Nutr. 2016 Nov;26(6):352-359. doi: 10.1053/j.jrn.2016.01.015. Epub 2016 Feb 28. Erratum In: J Ren Nutr. 2017 Jan;27(1):74. — View Citation
Caria S, Cupisti A, Sau G, Bolasco P. The incremental treatment of ESRD: a low-protein diet combined with weekly hemodialysis may be beneficial for selected patients. BMC Nephrol. 2014 Oct 29;15:172. doi: 10.1186/1471-2369-15-172. — View Citation
Casino FG, Basile C. The variable target model: a paradigm shift in the incremental haemodialysis prescription. Nephrol Dial Transplant. 2017 Jan 1;32(1):182-190. doi: 10.1093/ndt/gfw339. — View Citation
Chan CT, Covic A, Craig JC, Davenport A, Kasiske BL, Kuhlmann MK, Levin NW, Li PK, Locatelli F, Rocco MV, Wheeler DC. Novel techniques and innovation in blood purification: a clinical update from Kidney Disease: Improving Global Outcomes. Kidney Int. 2013 Mar;83(3):359-71. doi: 10.1038/ki.2012.450. Epub 2013 Jan 16. — View Citation
Chertow GM, Levin NW, Beck GJ, Daugirdas JT, Eggers PW, Kliger AS, Larive B, Rocco MV, Greene T; Frequent Hemodialysis Network (FHN) Trials Group. Long-Term Effects of Frequent In-Center Hemodialysis. J Am Soc Nephrol. 2016 Jun;27(6):1830-6. doi: 10.1681/ASN.2015040426. Epub 2015 Oct 14. — View Citation
Clark EG, Bagshaw SM. Unnecessary renal replacement therapy for acute kidney injury is harmful for renal recovery. Semin Dial. 2015 Jan-Feb;28(1):6-11. doi: 10.1111/sdi.12300. Epub 2014 Oct 30. — View Citation
Daugirdas JT, Greene T, Rocco MV, Kaysen GA, Depner TA, Levin NW, Chertow GM, Ornt DB, Raimann JG, Larive B, Kliger AS; FHN Trial Group. Effect of frequent hemodialysis on residual kidney function. Kidney Int. 2013 May;83(5):949-58. doi: 10.1038/ki.2012.457. Epub 2013 Jan 23. — View Citation
Fernandez Lucas M, Teruel JL. Incremental hemodialysis schedule at the start of renal replacement therapy. Nefrologia. 2017 Jan-Feb;37(1):1-4. doi: 10.1016/j.nefro.2016.08.002. Epub 2016 Oct 1. No abstract available. English, Spanish. — View Citation
Libetta C, Esposito P, Dal Canton A. Once-weekly hemodialysis: a single-center experience. Am J Kidney Dis. 2015 Feb;65(2):343. doi: 10.1053/j.ajkd.2014.07.034. No abstract available. — View Citation
Mathew AT, Fishbane S, Obi Y, Kalantar-Zadeh K. Preservation of residual kidney function in hemodialysis patients: reviving an old concept. Kidney Int. 2016 Aug;90(2):262-271. doi: 10.1016/j.kint.2016.02.037. Epub 2016 May 12. — View Citation
National Kidney Foundation. KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 update. Am J Kidney Dis. 2015 Nov;66(5):884-930. doi: 10.1053/j.ajkd.2015.07.015. Erratum In: Am J Kidney Dis. 2016 Mar;67(3):534. — View Citation
Obi Y, Streja E, Rhee CM, Ravel V, Amin AN, Cupisti A, Chen J, Mathew AT, Kovesdy CP, Mehrotra R, Kalantar-Zadeh K. Incremental Hemodialysis, Residual Kidney Function, and Mortality Risk in Incident Dialysis Patients: A Cohort Study. Am J Kidney Dis. 2016 Aug;68(2):256-265. doi: 10.1053/j.ajkd.2016.01.008. Epub 2016 Feb 9. — View Citation
Parra Moncasi E, Arenas Jimenez MD, Alonso M, Martinez MF, Gamen Pardo A, Rebollo P, Ortega Montoliu T, Martinez Terrer T, Alvarez-Ude F; Grupo de Gestion de la Calidad de la Sociedad Espanola de Nefrologia. Multicentre study of haemodialysis costs. Nefrologia. 2011;31(3):299-307. doi: 10.3265/Nefrologia.pre2011.Apr.10813. English, Spanish. — View Citation
Patel N, Hu SL. Preserving residual renal function in dialysis: what we know. Semin Dial. 2015 May-Jun;28(3):250-8. doi: 10.1111/sdi.12302. Epub 2014 Sep 18. — View Citation
Rocco MV, Daugirdas JT, Greene T, Lockridge RS, Chan C, Pierratos A, Lindsay R, Larive B, Chertow GM, Beck GJ, Eggers PW, Kliger AS; FHN Trial Group. Long-term Effects of Frequent Nocturnal Hemodialysis on Mortality: The Frequent Hemodialysis Network (FHN) Nocturnal Trial. Am J Kidney Dis. 2015 Sep;66(3):459-68. doi: 10.1053/j.ajkd.2015.02.331. Epub 2015 Apr 8. — View Citation
Shafi T, Jaar BG, Plantinga LC, Fink NE, Sadler JH, Parekh RS, Powe NR, Coresh J. Association of residual urine output with mortality, quality of life, and inflammation in incident hemodialysis patients: the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) Study. Am J Kidney Dis. 2010 Aug;56(2):348-58. doi: 10.1053/j.ajkd.2010.03.020. Epub 2010 Jun 3. — View Citation
Suri RS, Larive B, Sherer S, Eggers P, Gassman J, James SH, Lindsay RM, Lockridge RS, Ornt DB, Rocco MV, Ting GO, Kliger AS; Frequent Hemodialysis Network Trial Group. Risk of vascular access complications with frequent hemodialysis. J Am Soc Nephrol. 2013 Feb;24(3):498-505. doi: 10.1681/ASN.2012060595. Epub 2013 Feb 7. — View Citation
Termorshuizen F, Dekker FW, van Manen JG, Korevaar JC, Boeschoten EW, Krediet RT; NECOSAD Study Group. Relative contribution of residual renal function and different measures of adequacy to survival in hemodialysis patients: an analysis of the Netherlands Cooperative Study on the Adequacy of Dialysis (NECOSAD)-2. J Am Soc Nephrol. 2004 Apr;15(4):1061-70. doi: 10.1097/01.asn.0000117976.29592.93. — View Citation
Toth-Manikowski SM, Shafi T. Hemodialysis Prescription for Incident Patients: Twice Seems Nice, But Is It Incremental? Am J Kidney Dis. 2016 Aug;68(2):180-183. doi: 10.1053/j.ajkd.2016.04.005. No abstract available. — View Citation
van der Wal WM, Noordzij M, Dekker FW, Boeschoten EW, Krediet RT, Korevaar JC, Geskus RB; Netherlands Cooperative Study on the Adequacy of Dialysis Study Group (NECOSAD). Full loss of residual renal function causes higher mortality in dialysis patients; findings from a marginal structural model. Nephrol Dial Transplant. 2011 Sep;26(9):2978-83. doi: 10.1093/ndt/gfq856. Epub 2011 Feb 11. — View Citation
Vilar E, Wellsted D, Chandna SM, Greenwood RN, Farrington K. Residual renal function improves outcome in incremental haemodialysis despite reduced dialysis dose. Nephrol Dial Transplant. 2009 Aug;24(8):2502-10. doi: 10.1093/ndt/gfp071. Epub 2009 Feb 24. — View Citation
Wong J, Vilar E, Davenport A, Farrington K. Incremental haemodialysis. Nephrol Dial Transplant. 2015 Oct;30(10):1639-48. doi: 10.1093/ndt/gfv231. Epub 2015 Jun 1. — View Citation
Zhang M, Wang M, Li H, Yu P, Yuan L, Hao C, Chen J, Kalantar-Zadeh K. Association of initial twice-weekly hemodialysis treatment with preservation of residual kidney function in ESRD patients. Am J Nephrol. 2014;40(2):140-50. doi: 10.1159/000365819. Epub 2014 Aug 23. — View Citation
* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival rate | Assess and compare survival in subjects with one session a week as an RRT starting regimen, compared to those patients who start RRT with the conventional method | 24 months | |
Secondary | Hospital admissions | Number of hospitalizations, for any cause; and number of days hospitalized for any cause | 24 months | |
Secondary | Residual Kidney Function (RRF) maintenance . | Reduction of glomerular filtration rate (GFR) and tubular function. Average urine volume and percentage of patients with anuria (=200ml/day in two consecutive measurements). | 24 months | |
Secondary | Analysis of anemia | Mean hemoglobin levels and Proportion of patients with Hb measurement inside the target range (10.5-12 g/dl) and The erythropoietin resistance index (ERI): ERI = weekly EPO (in UI)/patient's weight (in kg)/Hb (in gr/dl) | 3, 6, 9, 12, 18 and 24 months | |
Secondary | Bone-mineral metabolism | Mean levels of calcium, phosphorus and intac PTH levels. Estimate the percentage of patients within the therapeutic range; Calcium 8,4-9,5mg/dl, Phosphorus 3,5-5,5mg/dl and iPTH 150-300 pg/dl. | 3, 6, 9, 12, 18 and 24 months | |
Secondary | Hypertrophic cardiomyopathy levels | Basal, anual and end of the follow-un visit | ||
Secondary | Estimation of the effect of treatment on quality of life | Quality of life survey values from Kidney Disease and Quality of Life (KDQOL'36 Spanish) will be registered. | 3, 6, 9, 12, 18 and 24 months | |
Secondary | Assessing RRT efficiency (costs) | The number of sessions perform in subjects of incremental HDF group Vs number of sessions in the conventional HD group. The cost of each session is defined by the public contest for private haemodialysis clinics arranged by (that work to) the Health Service of Extremadura. | 12 and 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT01691196 -
Inflammation in Peritoneal Dialysis Patients: Effect of Obesity
|
||
Completed |
NCT00125775 -
Does Extra-High Dose Hepatitis B Vaccination Confer Longer Serological Protection in Peritoneal Dialysis Patients?
|
Phase 4 | |
Completed |
NCT00035178 -
Pharmacokinetics/Pharmacodynamics of Argatroban Injection in End-Stage Renal Disease Patients Undergoing Hemodialysis
|
Phase 4 | |
Completed |
NCT01233882 -
Bosutinib In Subjects With Renal Impairment
|
Phase 1 |