Anemia of Chronic Kidney DiseasePhase 4NCT04959578

Comparison of Darbepoetin Alpha and Recombinant Human Erythropoietin for Treatment of Anemia in Children With Chronic Kidney Disease

A Phase 4 study testing Recombinant human erythropoietin and Darbepoetin Alfa in people with Anemia of Chronic Kidney Disease, run by Rufaida Mazahir at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The present study was designed to determine whether or not darbepoetin alfa is non-inferior to recombinant human erythropoietin in the treatment of anemia in children with chronic kidney disease stage 3-5 (on or not on dialysis). Read more about this study

Who is it for?: Ages 1 year to 18 years
Conditions the study is for: Anemia of Chronic Kidney Disease
What is being tested?: Recombinant human erythropoietin and Darbepoetin Alfa
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteIndia
Study dates: 1 Feb 2018to 31 Jan 2019
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Age 1-18 years.
CKD patients stages 3 to 5 (on or not on dialysis).
Baseline hemoglobin 9 - 12 g/dL.
Subject should have adequate transferrin saturation (≥20%) and serum ferritin (≥100 ng/mL).
Stable erythropoietin therapy for 8 weeks ( defined as a ≤25% change in prescribed dose, no change in the route of administration and no more than one missed or withheld dose).

Who cannot join

Subject scheduled for a living-related kidney transplant.
Subject with uncontrolled hypertension.
HIV positive patient.
The patient with known hematologic disease or cause of anemia other than renal disease.
Patient with a history of seizure disorder or received antiepileptic medication for a seizure disorder within 6 months prior to enrolment.
Hyperparathyroidism (Intact parathyroid hormone more than 1500 pg/ml or biopsy proven marrow fibrosis).

Show all 10Show fewer

Major surgery within 12 weeks.
Active inflammatory disease within 8 weeks of randomization requiring immunosuppressive therapy.
Clinical evidence of malignancy.
Blood transfusion within 8 weeks prior to initiation of therapy.

Trial locations and contacts

1 site in 1 country.

India1 site

Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060

Other trials in India

About this study

Official title: Comparison of Darbepoetin Alpha and Recombinant Human Erythropoietin as Erythropoietic Agents for Treatment of Anemia in Pediatric Chronic Kidney Disease Patients

Read the detailed description

PRIMARY OBJECTIVE:

To demonstrate that Darbepoetin alpha is non-inferior to erythropoietin for the treatment of anemia in subjects with chronic kidney disease (CKD) stage 3-5 (on or not on dialysis).

SECONDARY OBJECTIVE:

To determine the safety and tolerability of Darbepoetin alpha in the treatment of anemia in the pediatric population with CKD stage 3-5.

STUDY DESIGN:

An open-label, randomized, non-inferiority study of darbepoetin alpha (DA) and recombinant human erythropoietin(rHuEpo) for the treatment of anemia in children with chronic kidney disease stages 3 to 5 (on or not on dialysis)

DURATION OF STUDY:

The study was conducted over a period of 1 year (from 1st February 2018 to 31st January 2019).

STUDY SETTING:

This study was conducted in the Division of Pediatric Nephrology, Department of Paediatrics, Institute of Child Health, Sir Ganga Ram Hospital, New Delhi, India.

CONSENT:

A prior written informed consent was obtained from parents/ legal guardians of eligible children for participation in the study.

SAMPLE SIZE CALCULATION:

The primary objective of the study is to assess the non-inferiority of darbepoetin alfa compared with rHuEpo. Using a previous study with similar protocol [1], considering darbepoetin alfa and rHuEpo as equipotent, we accepted a type I error of 0.05 and a type II error of 0.80 for detecting a true difference. A 1.0 or greater difference in mean change in Hb variable between two groups was considered clinically significant. An estimate of standard deviation in dependent variables was assumed as 1.5. As a result, we have calculated that minimum of 28 patients are needed in each group (total-56) in order to obtain 5% type 1 error and a 80% power of detecting a difference of 1.0 or more. However, due to time constraints a sample of minimum 15 subjects in each group was planned.

Note: Sample size estimation was done by powerandsamplesize.com.

METHODOLOGY:

The study was conducted in the following phases:

Screening Phase (Visit 1, Day -14 to Day -1) The potential subjects were screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the parent/subject.
Enrollment and Randomization Phase (Visit 2, Day 0) Subjects were randomized in two groups in a 1:1 ratio by computer generated mechanism (graphpad.com) as follows:
Treatment arm 1: Erythropoietin
Treatment arm 2: Darbepoetin alfa
Treatment Phase (Visit 3, Day 1 to Visit 8, Day 168) Patients received respective treatments for 24 week period and they were followed up every 4 weeks. Both rHuEpo and darbepoetin alfa were titrated over the first 23 weeks of the study to maintain the subjects' Hb levels between 11 to 12 g/dl without adjusting the dosing frequency. Route of administration was subcutaneous. Efficacy was determined between weeks 24 and 28.

ETHICS APPROVAL The study was approved by the Institutional Ethics Committee of Sir Ganga Ram Hospital, New Delhi.

Conditions: Anemia of Chronic Kidney Disease
Being tested: Recombinant human erythropoietin, Darbepoetin Alfa
Keywords: Anemia, Chronic kidney disease, Darbepoetin alpha, Erythropoietin, Pediatric
Medical subject headings: Anemia, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant human erythropoietinDrug
Dose, route and schedule was kept same as previous erythropoietin dose at randomization; adjusted as necessary (+/- 25% of the starting dose) to maintain Hb within 11 - 12 g/dL.
Darbepoetin AlfaDrug
Dose conversion (100U erythropoietin = 0.42 mcg darbeopoetin). DA dose was kept once weekly (QW) if previously receiving rHuEpo ≥2 times a week, or Q2W if previously receiving rHuEpo <2 times a week. Dose was adjusted as necessary (+/- 25% of the starting dose) to maintain Hb within 11 - 12 g/dL.

Study groups in NCT04959578
Study group	Role	What they receive
Erythropoietin	Active comparator	Recombinant Human Erythropoietin Receives: Drug: Recombinant human erythropoietin
Darbepoetin alfa	Experimental	Darbepoetin Alpha Receives: Drug: Darbepoetin Alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean change in hemoglobin (Hb) between baseline and the evaluation period
Hb in mg/dL
Measured: 24 -28 week

Secondary outcomes (1)

Incidence of treatment-related adverse events in both groups during study period
Measured: 0-28 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201831 Jan 2019

First posted13 Jul 2021
Study start1 Feb 2018
Primary completion31 Jan 2019
Study completion31 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Anemia of Chronic Kidney DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04959578
Sponsor's protocol ID: EC/01/18/1317
Status last verified: Jul 2021
First submitted: 3 Jul 2021
Last updated: 13 Jul 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The IPD might be shared if requested from the sponsor-investigator.

Publications

Warady BA, Arar MY, Lerner G, Nakanishi AM, Stehman-Breen C. Darbepoetin alfa for the treatment of anemia in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2006 Aug;21(8):1144-52. doi: 10.1007/s00467-006-0071-0. Epub 2006 May 25.
PubMed 16724235
Koshy SM, Geary DF. Anemia in children with chronic kidney disease. Pediatr Nephrol. 2008 Feb;23(2):209-19. doi: 10.1007/s00467-006-0381-2. Epub 2007 Jan 24.
PubMed 17245602
Klang B, Bjorvell H, Clyne N. Quality of life in predialytic uremic patients. Qual Life Res. 1996 Feb;5(1):109-16. doi: 10.1007/BF00435975.
PubMed 8901373
Gerson A, Hwang W, Fiorenza J, Barth K, Kaskel F, Weiss L, Zelikovsky N, Fivush B, Furth S. Anemia and health-related quality of life in adolescents with chronic kidney disease. Am J Kidney Dis. 2004 Dec;44(6):1017-23. doi: 10.1053/j.ajkd.2004.08.024.
PubMed 15558522
Mitsnefes MM, Daniels SR, Schwartz SM, Meyer RA, Khoury P, Strife CF. Severe left ventricular hypertrophy in pediatric dialysis: prevalence and predictors. Pediatr Nephrol. 2000 Sep;14(10-11):898-902. doi: 10.1007/s004670000303.
PubMed 10975295
Chavers BM, Herzog CA. The spectrum of cardiovascular disease in children with predialysis chronic kidney disease. Adv Chronic Kidney Dis. 2004 Jul;11(3):319-27. doi: 10.1053/j.arrt.2004.04.002.
PubMed 15241746
Pickett JL, Theberge DC, Brown WS, Schweitzer SU, Nissenson AR. Normalizing hematocrit in dialysis patients improves brain function. Am J Kidney Dis. 1999 Jun;33(6):1122-30. doi: 10.1016/S0272-6386(99)70150-2.
PubMed 10352201
Pattaragarn A, Warady BA, Sabath RJ. Exercise capacity in pediatric patients with end-stage renal disease. Perit Dial Int. 2004 May-Jun;24(3):274-80.
PubMed 15185776
Sietsema KE, Hiatt WR, Esler A, Adler S, Amato A, Brass EP. Clinical and demographic predictors of exercise capacity in end-stage renal disease. Am J Kidney Dis. 2002 Jan;39(1):76-85. doi: 10.1053/ajkd.2002.29884.
PubMed 11774105
Xia H, Ebben J, Ma JZ, Collins AJ. Hematocrit levels and hospitalization risks in hemodialysis patients. J Am Soc Nephrol. 1999 Jun;10(6):1309-16. doi: 10.1681/ASN.V1061309.
PubMed 10361870
Ma JZ, Ebben J, Xia H, Collins AJ. Hematocrit level and associated mortality in hemodialysis patients. J Am Soc Nephrol. 1999 Mar;10(3):610-9. doi: 10.1681/ASN.V103610.
PubMed 10073612
Warady BA, Ho M. Morbidity and mortality in children with anemia at initiation of dialysis. Pediatr Nephrol. 2003 Oct;18(10):1055-62. doi: 10.1007/s00467-003-1214-1. Epub 2003 Jul 23.
PubMed 12883982
VanDeVoorde RG, Warady BA. Management of chronic kidney disease. In: Avner ED, Harmon WE, Niaudet P, Yoshikawa N (eds). Pediatric Nephrology, 6th edn. Springer-Verlag, Berlin, 2009; 1661-92.
Lerner G, Kale AS, Warady BA, Jabs K, Bunchman TE, Heatherington A, Olson K, Messer-Mann L, Maroni BJ. Pharmacokinetics of darbepoetin alfa in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2002 Nov;17(11):933-7. doi: 10.1007/s00467-002-0932-0. Epub 2002 Sep 14.
PubMed 12432437
Mazahir R, Anand K, Pruthi PK. Comparison of darbepoetin alpha and recombinant human erythropoietin for treatment of anemia in pediatric chronic kidney disease: a non-inferiority trial from India. Eur J Pediatr. 2023 Jan;182(1):101-109. doi: 10.1007/s00431-022-04650-1. Epub 2022 Oct 11.
PubMed 36220980

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Darbepoetin Alpha and Recombinant Human Erythropoietin as Erythropoietic Agents for Treatment of Anemia in Pediatric Chronic Kidney Disease Patients
ClinicalTrials.gov ID: NCT04959578
Acronym / sponsor ID: EC/01/18/1317
Conditions: Anemia of Chronic Kidney Disease
Keywords: Anemia, Chronic kidney disease, Darbepoetin alpha, Erythropoietin, Pediatric
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Rufaida MazahirUniversity, hospital or other
Study start: 1 Feb 2018 (actual)
Primary completion: 31 Jan 2019 (actual)
Study completion: 31 Jan 2019 (actual)
First posted: 13 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

To demonstrate that Darbepoetin alpha is non-inferior to erythropoietin for the treatment of anemia in subjects with chronic kidney disease (CKD) stage 3-5 (on or not on dialysis).

SECONDARY OBJECTIVE:

To determine the safety and tolerability of Darbepoetin alpha in the treatment of anemia in the pediatric population with CKD stage 3-5.

STUDY DESIGN:

DURATION OF STUDY:

The study was conducted over a period of 1 year (from 1st February 2018 to 31st January 2019).

STUDY SETTING:

This study was conducted in the Division of Pediatric Nephrology, Department of Paediatrics, Institute of Child Health, Sir Ganga Ram Hospital, New Delhi, India.

CONSENT:

A prior written informed consent was obtained from parents/ legal guardians of eligible children for participation in the study.

SAMPLE SIZE CALCULATION:

Note: Sample size estimation was done by powerandsamplesize.com.

METHODOLOGY:

The study was conducted in the following phases:

Screening Phase (Visit 1, Day -14 to Day -1) The potential subjects were screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the parent/subject.
Enrollment and Randomization Phase (Visit 2, Day 0) Subjects were randomized in two groups in a 1:1 ratio by computer generated mechanism (graphpad.com) as follows:
Treatment arm 1: Erythropoietin
Treatment arm 2: Darbepoetin alfa
Treatment Phase (Visit 3, Day 1 to Visit 8, Day 168) Patients received respective treatments for 24 week period and they were followed up every 4 weeks. Both rHuEpo and darbepoetin alfa were titrated over the first 23 weeks of the study to maintain the subjects' Hb levels between 11 to 12 g/dl without adjusting the dosing frequency. Route of administration was subcutaneous. Efficacy was determined between weeks 24 and 28.

ETHICS APPROVAL The study was approved by the Institutional Ethics Committee of Sir Ganga Ram Hospital, New Delhi.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Erythropoietin	Active comparator	Drug: Recombinant human erythropoietinRecombinant Human Erythropoietin
Darbepoetin alfa	Experimental	Drug: Darbepoetin AlfaDarbepoetin Alpha

Who may qualify

Ages: 1 year to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Age 1-18 years.
CKD patients stages 3 to 5 (on or not on dialysis).
Baseline hemoglobin 9 - 12 g/dL.
Subject should have adequate transferrin saturation (≥20%) and serum ferritin (≥100 ng/mL).
Stable erythropoietin therapy for 8 weeks ( defined as a ≤25% change in prescribed dose, no change in the route of administration and no more than one missed or withheld dose).

Key exclusion criteria (10 listed)

Subject scheduled for a living-related kidney transplant.
Subject with uncontrolled hypertension.
HIV positive patient.
The patient with known hematologic disease or cause of anemia other than renal disease.
Patient with a history of seizure disorder or received antiepileptic medication for a seizure disorder within 6 months prior to enrolment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Recombinant human erythropoietinDose, route and schedule was kept same as previous erythropoietin dose at randomization; adjusted as necessary (+/- 25% of the starting dose) to maintain Hb within 11 - 12 g/dL.	Drug	Erythropoietin
Darbepoetin AlfaDose conversion (100U erythropoietin = 0.42 mcg darbeopoetin). DA dose was kept once weekly (QW) if previously receiving rHuEpo ≥2 times a week, or Q2W if previously receiving rHuEpo <2 times a week. Dose was adjusted as necessary (+/- 25% of the starting dose) to maintain Hb within 11 - 12 g/dL.	Drug	Darbepoetin alfa

Primary outcome

Mean change in hemoglobin (Hb) between baseline and the evaluation period
Time frame: 24 -28 week
Hb in mg/dL

1 secondary outcome

Incidence of treatment-related adverse events in both groups during study period
Time frame: 0-28 week

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
Background: PubMed 16724235Warady BA, Arar MY, Lerner G, Nakanishi AM, Stehman-Breen C. Darbepoetin alfa for the treatment of anemia in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2006 Aug;21(8):1144-52. doi: 10.1007/s00467-006-0071-0. Epub 2006 May 25.
Background: PubMed 17245602Koshy SM, Geary DF. Anemia in children with chronic kidney disease. Pediatr Nephrol. 2008 Feb;23(2):209-19. doi: 10.1007/s00467-006-0381-2. Epub 2007 Jan 24.
Background: PubMed 8901373Klang B, Bjorvell H, Clyne N. Quality of life in predialytic uremic patients. Qual Life Res. 1996 Feb;5(1):109-16. doi: 10.1007/BF00435975.
Background: PubMed 15558522Gerson A, Hwang W, Fiorenza J, Barth K, Kaskel F, Weiss L, Zelikovsky N, Fivush B, Furth S. Anemia and health-related quality of life in adolescents with chronic kidney disease. Am J Kidney Dis. 2004 Dec;44(6):1017-23. doi: 10.1053/j.ajkd.2004.08.024.
Background: PubMed 10975295Mitsnefes MM, Daniels SR, Schwartz SM, Meyer RA, Khoury P, Strife CF. Severe left ventricular hypertrophy in pediatric dialysis: prevalence and predictors. Pediatr Nephrol. 2000 Sep;14(10-11):898-902. doi: 10.1007/s004670000303.
Background: PubMed 15241746Chavers BM, Herzog CA. The spectrum of cardiovascular disease in children with predialysis chronic kidney disease. Adv Chronic Kidney Dis. 2004 Jul;11(3):319-27. doi: 10.1053/j.arrt.2004.04.002.
Background: PubMed 10352201Pickett JL, Theberge DC, Brown WS, Schweitzer SU, Nissenson AR. Normalizing hematocrit in dialysis patients improves brain function. Am J Kidney Dis. 1999 Jun;33(6):1122-30. doi: 10.1016/S0272-6386(99)70150-2.
Background: PubMed 15185776Pattaragarn A, Warady BA, Sabath RJ. Exercise capacity in pediatric patients with end-stage renal disease. Perit Dial Int. 2004 May-Jun;24(3):274-80.
Background: PubMed 11774105Sietsema KE, Hiatt WR, Esler A, Adler S, Amato A, Brass EP. Clinical and demographic predictors of exercise capacity in end-stage renal disease. Am J Kidney Dis. 2002 Jan;39(1):76-85. doi: 10.1053/ajkd.2002.29884.
Background: PubMed 10361870Xia H, Ebben J, Ma JZ, Collins AJ. Hematocrit levels and hospitalization risks in hemodialysis patients. J Am Soc Nephrol. 1999 Jun;10(6):1309-16. doi: 10.1681/ASN.V1061309.
Background: PubMed 10073612Ma JZ, Ebben J, Xia H, Collins AJ. Hematocrit level and associated mortality in hemodialysis patients. J Am Soc Nephrol. 1999 Mar;10(3):610-9. doi: 10.1681/ASN.V103610.
Background: PubMed 12883982Warady BA, Ho M. Morbidity and mortality in children with anemia at initiation of dialysis. Pediatr Nephrol. 2003 Oct;18(10):1055-62. doi: 10.1007/s00467-003-1214-1. Epub 2003 Jul 23.
Individual participant dataSharing planned: No. The IPD might be shared if requested from the sponsor-investigator.

Related trials for Anemia of Chronic Kidney Disease

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RecruitingObservational study
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Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
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Study of CTX001 in Adults With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rufaida Mazahir, MD, FNB principal investigator

Sir Ganga Ram Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Recombinant human erythropoietin and Darbepoetin Alfa in people with Anemia of Chronic Kidney Disease, run by Rufaida Mazahir at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in hemoglobin (Hb) between baseline and the evaluation period (time frame: 24 -28 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04959578, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.