Renal AnemiaPhase 4NCT06830941
Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients
A Phase 4 study testing Iron isomaltoside and Ferrous succinate in people with Renal Anemia and Peritoneal Dialysis (PD), run by Xie Jingyuan, MD.
Trial summary
This is a prospective multicenter randomized controlled clinical study. The goal of this clinical trial is to learn if intravenous iron isomaltoside injection use is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Anemia, Peritoneal Dialysis (PD)
- What is being tested?
- Iron isomaltoside and Ferrous succinate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females who are ≥ 18 years and on PD treatment for ≥90 days, body weight≥50Kg
- Hemoglobin(Hb）≤110 g/L at screening phase
- Serum ferritin(SF）≤200 μg/L or transferrin saturation(TSAT）≤20% at screening phase
- No oral or intravenous iron use within 4 weeks prior to screening.
- No hypoxia-inducible factor prolyl hydroxylase inhibitor（HIF-PHI）used or other erythropoiesis-stimulating agent（ESA）except for erythropoietin (EPO) used in the past 4 weeks prior to screening
- Stable doses of erythropoiesis-stimulating agents (ESA) with a change of dose ≤20% during the past 4 weeks.
- Willing to participate and signed the informed consent form
Who cannot join
- Anemia predominantly caused by other diseases rather than renal diseases according to the investigator's judgement. (eg. bleeding, hematological diseases, anemia due to autoimmune diseases)
- History of disturbances in iron utilisation.(eg. hemochromatosis and hemosiderosis）
- Anemia due to lack of folate or vitamin B12：folate<6.8nmol/L（3ng/ml）and(or) Vitamin B12<74pmol/L（100pg/ml）at screening phase
- Histories of serious allergies to iron
- Obvious liver dysfunction：ALT>3×ULN and/or AST>3×ULN，or total bilirubin>1.5×ULN
- Active acute or chronic infection(clinically diagnosed)
Show all 16Show fewer
- Uncontrolled secondary hyperparathyroidism：PTH or iPTH>9×ULN；
- History of malignancy within 5 years
- Acute coronary syndrome, strokes (except for lacunar cerebral infarction), serious thromboembolism (eg. DVT or PE) within 6 months before the screening period
- NYHA grade III or IV of congestive heart failure or severe arrythmia(including ventricular tachycardia, ventricular fibrillation, AV-block III etc.) within 6 months before screening
- Pregnant or during lactation period or not willing to get contraception
- Planning to receive renal transplantation within 2 months
- Accepted blood transfusion within 3 months.
- Serum ferritin，SF>500 μg/L
- Planning to recieve the treatment as operations, chemotherapies or radiotherapies etc. during the research period
- Other situations not suitable for inclusion decided by researchers. Rescreening is allowed if it failed in the first time of screening.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Iron Isomaltoside in the Treatment of Peritoneal Dialysis Patients with Renal Related Anemia: a Randomized Controlled Trial
This is a prospective multicenter randomized controlled clinical study. The goal of this clinical trial is to learn if intravenous iron isomaltoside injection use is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets.
The main questions to answer are:
Read more
- Changes in hemoglobin concentration from baseline to week 8 after the use of single dose intravenous iron isomaltoside injection in peritoneal dialysis patients with renal anemia.
- If intravenous iron isomaltoside injection use is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets.
Participants will:
- be randomized 1:1 to two groups, either Iron isomaltoside Group (Group A, experimental group) or Ferrous succinate Group (Group B, control group).
- Patients in Iron isomaltoside Group will receive a single dose of intravenous iron isomaltoside injection, the dose of which is set at 1000 mg. Patients in Ferrous succinate Group will receive ferrous succinate treatment orally given as 200mg twice a day for 8 weeks (containing iron element 7840mg in total).
- Patients will be followed up for 8 weeks.
Read the detailed description
This is a prospective multicenter randomized controlled clinical study. The purpose of this study is to evaluate the efficacy and safety of single dose intravenous iron isomaltoside comparing with daily oral ferrous succinate in the treatment of renal anemia among patients on peritoneal dialysis.
A total of 124 patients will be enrolled. The primary endpoint is hemoglobin change from baseline to week 8, the secondary endpoint is hemoglobin change from baseline to week 4. Other secondary endpoints include the results of iron metabolism, reticulocytes, composite cardiovascular events, laboratory and safety parameters. The expected result is that intravenous iron isomaltoside is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets.
- Conditions
- Renal Anemia, Peritoneal Dialysis (PD)
- Being tested
- Iron isomaltoside, Ferrous succinate
- Keywords
- peritoneal dialysis, renal anemia, iron isomaltoside, iron treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron isomaltosideDrug
Also called Intravenous iron isomaltoside
Intravenous infusion of 1000mg iron isomaltoside as a single dose for over 15min. Iron isomaltoside 1000mg was diluted in 100ml of 0.9% saline.
Ferrous succinateDrug
Also called Oral ferrous succinate
Patients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Iron isomaltoside Group | Experimental | Intravenous infusion of 1000mg iron isomaltoside as a single dose for over 15min. Iron isomaltoside 1000mg was diluted in 100ml of 0.9% saline. Receives: Drug: Iron isomaltoside |
| Ferrous succinate Group | Active comparator | Patients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks(containing iron element 7840mg in total). Receives: Drug: Ferrous succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hemoglobin concentration from baseline to week 8
Full blood count
Measured: Screening period，Day 1，Week 1，Week 4，Week 8
Secondary outcomes (5)
Changes in hemoglobin concentration from baseline to week 4
Full blood count
Measured: Screening period，Day 1，Week 1，Week 4
Iron metabolism indices and reticulocyte count at week 8
Iron metabolism indices and reticulocyte count
Measured: Screening period，Day 1，Week 1，Week 4，Week 8
Iron metabolism indices and reticulocyte count at week 4
Iron metabolism indices and reticulocyte count
Measured: Screening period，Day 1，Week 1，Week 4
Compound cardiovascular adverse events at Week 8
Recording and observation with the reference of clinical symptoms and the results of EKG, NT-proBNP, cardiac troponin, CK-MB and myoglobin etc.
Measured: Through study completion, an average of 1 year
Adverse Events
Recording and observation with the reference of clinical symptoms and the results of laboratory indices and other indices for safety
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start15 Feb 2025 (estimated)
- Primary completion9 Feb 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Renal AnemiaStudies 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
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xie Jingyuan, MD
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Songjiang Hospital, Shanghai Jiao Tong University School of Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Chinese People's Liberation Army No 455 Hospital
- Responsible party
- Sponsor-investigator, Xie Jingyuan, MD, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830941
- Sponsor's protocol ID
- Iron isomaltoside-PD
- Status last verified
- Jan 2025
- First submitted
- 10 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalra PA, Bhandari S, Saxena S, Agarwal D, Wirtz G, Kletzmayr J, Thomsen LL, Coyne DW. A randomized trial of iron isomaltoside 1000 versus oral iron in non-dialysis-dependent chronic kidney disease patients with anaemia. Nephrol Dial Transplant. 2016 Apr;31(4):646-55. doi: 10.1093/ndt/gfv293. Epub 2015 Aug 6.
PubMed 26250435Bhandari S, Kalra PA, Kothari J, Ambuhl PM, Christensen JH, Essaian AM, Thomsen LL, Macdougall IC, Coyne DW. A randomized, open-label trial of iron isomaltoside 1000 (Monofer(R)) compared with iron sucrose (Venofer(R)) as maintenance therapy in haemodialysis patients. Nephrol Dial Transplant. 2015 Sep;30(9):1577-89. doi: 10.1093/ndt/gfv096. Epub 2015 Apr 28.
PubMed 25925701Bhandari S, Kalra PA, Berkowitz M, Belo D, Thomsen LL, Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial. Nephrol Dial Transplant. 2021 Jan 1;36(1):111-120. doi: 10.1093/ndt/gfaa011.
PubMed 32049331Futterer S, Andrusenko I, Kolb U, Hofmeister W, Langguth P. Structural characterization of iron oxide/hydroxide nanoparticles in nine different parenteral drugs for the treatment of iron deficiency anaemia by electron diffraction (ED) and X-ray powder diffraction (XRPD). J Pharm Biomed Anal. 2013 Dec;86:151-60. doi: 10.1016/j.jpba.2013.08.005. Epub 2013 Aug 14.
PubMed 23998966Jahn MR, Andreasen HB, Futterer S, Nawroth T, Schunemann V, Kolb U, Hofmeister W, Munoz M, Bock K, Meldal M, Langguth P. A comparative study of the physicochemical properties of iron isomaltoside 1000 (Monofer), a new intravenous iron preparation and its clinical implications. Eur J Pharm Biopharm. 2011 Aug;78(3):480-91. doi: 10.1016/j.ejpb.2011.03.016. Epub 2011 Mar 23.
PubMed 21439379Auerbach M, Henry D, DeLoughery TG. Intravenous ferric derisomaltose for the treatment of iron deficiency anemia. Am J Hematol. 2021 Jun 1;96(6):727-734. doi: 10.1002/ajh.26124. Epub 2021 Feb 26.
PubMed 33580972Auerbach M, Gafter-Gvili A, Macdougall IC. Intravenous iron: a framework for changing the management of iron deficiency. Lancet Haematol. 2020 Apr;7(4):e342-e350. doi: 10.1016/S2352-3026(19)30264-9.
PubMed 32220343Bazeley JW, Wish JB. Recent and Emerging Therapies for Iron Deficiency in Anemia of CKD: A Review. Am J Kidney Dis. 2022 Jun;79(6):868-876. doi: 10.1053/j.ajkd.2021.09.017. Epub 2021 Nov 7.
PubMed 34758368Cancelo-Hidalgo MJ, Castelo-Branco C, Palacios S, Haya-Palazuelos J, Ciria-Recasens M, Manasanch J, Perez-Edo L. Tolerability of different oral iron supplements: a systematic review. Curr Med Res Opin. 2013 Apr;29(4):291-303. doi: 10.1185/03007995.2012.761599. Epub 2013 Feb 6.
PubMed 23252877Drueke TB, Parfrey PS. Summary of the KDIGO guideline on anemia and comment: reading between the (guide)line(s). Kidney Int. 2012 Nov;82(9):952-60. doi: 10.1038/ki.2012.270. Epub 2012 Aug 1.
PubMed 22854645Batchelor EK, Kapitsinou P, Pergola PE, Kovesdy CP, Jalal DI. Iron Deficiency in Chronic Kidney Disease: Updates on Pathophysiology, Diagnosis, and Treatment. J Am Soc Nephrol. 2020 Mar;31(3):456-468. doi: 10.1681/ASN.2019020213. Epub 2020 Feb 10.
PubMed 32041774Molnar MZ, Mehrotra R, Duong U, Kovesdy CP, Kalantar-Zadeh K. Association of hemoglobin and survival in peritoneal dialysis patients. Clin J Am Soc Nephrol. 2011 Aug;6(8):1973-81. doi: 10.2215/CJN.01050211. Epub 2011 Jul 22.
PubMed 21784829Li S, Foley RN, Collins AJ. Anemia, hospitalization, and mortality in patients receiving peritoneal dialysis in the United States. Kidney Int. 2004 May;65(5):1864-9. doi: 10.1111/j.1523-1755.2004.00584.x.
PubMed 15086928Horl WH. Anaemia management and mortality risk in chronic kidney disease. Nat Rev Nephrol. 2013 May;9(5):291-301. doi: 10.1038/nrneph.2013.21. Epub 2013 Feb 26.
PubMed 23438972Fishbane S, Spinowitz B. Update on Anemia in ESRD and Earlier Stages of CKD: Core Curriculum 2018. Am J Kidney Dis. 2018 Mar;71(3):423-435. doi: 10.1053/j.ajkd.2017.09.026. Epub 2018 Jan 11.
PubMed 29336855
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Iron Isomaltoside in the Treatment of Peritoneal Dialysis Patients with Renal Related Anemia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06830941
- Acronym / sponsor ID
- Iron isomaltoside-PD
- Conditions
- Renal Anemia, Peritoneal Dialysis (PD)
- Keywords
- peritoneal dialysis, renal anemia, iron isomaltoside, iron treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Xie Jingyuan, MDUniversity, hospital or other
- Collaborators
- RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Songjiang Hospital, Shanghai Jiao Tong University School of Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Chinese People's Liberation Army No 455 Hospital
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 9 Feb 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Feb 2025 (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.
This is a prospective multicenter randomized controlled clinical study. The goal of this clinical trial is to learn if intravenous iron isomaltoside injection use is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets.
The main questions to answer are:
- Changes in hemoglobin concentration from baseline to week 8 after the use of single dose intravenous iron isomaltoside injection in peritoneal dialysis patients with renal anemia.
- If intravenous iron isomaltoside injection use is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets.
Participants will:
- be randomized 1:1 to two groups, either Iron isomaltoside Group (Group A, experimental group) or Ferrous succinate Group (Group B, control group).
- Patients in Iron isomaltoside Group will receive a single dose of intravenous iron isomaltoside injection, the dose of which is set at 1000 mg. Patients in Ferrous succinate Group will receive ferrous succinate treatment orally given as 200mg twice a day for 8 weeks (containing iron element 7840mg in total).
- Patients will be followed up for 8 weeks.
Detailed description
This is a prospective multicenter randomized controlled clinical study. The purpose of this study is to evaluate the efficacy and safety of single dose intravenous iron isomaltoside comparing with daily oral ferrous succinate in the treatment of renal anemia among patients on peritoneal dialysis.
A total of 124 patients will be enrolled. The primary endpoint is hemoglobin change from baseline to week 8, the secondary endpoint is hemoglobin change from baseline to week 4. Other secondary endpoints include the results of iron metabolism, reticulocytes, composite cardiovascular events, laboratory and safety parameters. The expected result is that intravenous iron isomaltoside is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron isomaltoside Group | Experimental | Drug: Iron isomaltosideIntravenous infusion of 1000mg iron isomaltoside as a single dose for over 15min. Iron isomaltoside 1000mg was diluted in 100ml of 0.9% saline. |
| Ferrous succinate Group | Active comparator | Drug: Ferrous succinatePatients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks(containing iron element 7840mg in total). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females who are ≥ 18 years and on PD treatment for ≥90 days, body weight≥50Kg
- Hemoglobin(Hb）≤110 g/L at screening phase
- Serum ferritin(SF）≤200 μg/L or transferrin saturation(TSAT）≤20% at screening phase
- No oral or intravenous iron use within 4 weeks prior to screening.
- No hypoxia-inducible factor prolyl hydroxylase inhibitor（HIF-PHI）used or other erythropoiesis-stimulating agent（ESA）except for erythropoietin (EPO) used in the past 4 weeks prior to screening
Key exclusion criteria (16 listed)
- Anemia predominantly caused by other diseases rather than renal diseases according to the investigator's judgement. (eg. bleeding, hematological diseases, anemia due to autoimmune diseases)
- History of disturbances in iron utilisation.(eg. hemochromatosis and hemosiderosis）
- Anemia due to lack of folate or vitamin B12：folate<6.8nmol/L（3ng/ml）and(or) Vitamin B12<74pmol/L（100pg/ml）at screening phase
- Histories of serious allergies to iron
- Obvious liver dysfunction：ALT>3×ULN and/or AST>3×ULN，or total bilirubin>1.5×ULN
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 |
|---|---|---|
| Iron isomaltosideAlso: Intravenous iron isomaltosideIntravenous infusion of 1000mg iron isomaltoside as a single dose for over 15min. Iron isomaltoside 1000mg was diluted in 100ml of 0.9% saline. | Drug | Iron isomaltoside Group |
| Ferrous succinateAlso: Oral ferrous succinatePatients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks. | Drug | Ferrous succinate Group |
Primary outcome
Changes in hemoglobin concentration from baseline to week 8
Time frame: Screening period，Day 1，Week 1，Week 4，Week 8
Full blood count
5 secondary outcomes
Changes in hemoglobin concentration from baseline to week 4
Time frame: Screening period，Day 1，Week 1，Week 4
Iron metabolism indices and reticulocyte count at week 8
Time frame: Screening period，Day 1，Week 1，Week 4，Week 8
Iron metabolism indices and reticulocyte count at week 4
Time frame: Screening period，Day 1，Week 1，Week 4
Compound cardiovascular adverse events at Week 8
Time frame: Through study completion, an average of 1 year
Adverse Events
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Background: PubMed 26250435Kalra PA, Bhandari S, Saxena S, Agarwal D, Wirtz G, Kletzmayr J, Thomsen LL, Coyne DW. A randomized trial of iron isomaltoside 1000 versus oral iron in non-dialysis-dependent chronic kidney disease patients with anaemia. Nephrol Dial Transplant. 2016 Apr;31(4):646-55. doi: 10.1093/ndt/gfv293. Epub 2015 Aug 6.
- Background: PubMed 25925701Bhandari S, Kalra PA, Kothari J, Ambuhl PM, Christensen JH, Essaian AM, Thomsen LL, Macdougall IC, Coyne DW. A randomized, open-label trial of iron isomaltoside 1000 (Monofer(R)) compared with iron sucrose (Venofer(R)) as maintenance therapy in haemodialysis patients. Nephrol Dial Transplant. 2015 Sep;30(9):1577-89. doi: 10.1093/ndt/gfv096. Epub 2015 Apr 28.
- Background: PubMed 32049331Bhandari S, Kalra PA, Berkowitz M, Belo D, Thomsen LL, Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial. Nephrol Dial Transplant. 2021 Jan 1;36(1):111-120. doi: 10.1093/ndt/gfaa011.
- Background: PubMed 23998966Futterer S, Andrusenko I, Kolb U, Hofmeister W, Langguth P. Structural characterization of iron oxide/hydroxide nanoparticles in nine different parenteral drugs for the treatment of iron deficiency anaemia by electron diffraction (ED) and X-ray powder diffraction (XRPD). J Pharm Biomed Anal. 2013 Dec;86:151-60. doi: 10.1016/j.jpba.2013.08.005. Epub 2013 Aug 14.
- Background: PubMed 21439379Jahn MR, Andreasen HB, Futterer S, Nawroth T, Schunemann V, Kolb U, Hofmeister W, Munoz M, Bock K, Meldal M, Langguth P. A comparative study of the physicochemical properties of iron isomaltoside 1000 (Monofer), a new intravenous iron preparation and its clinical implications. Eur J Pharm Biopharm. 2011 Aug;78(3):480-91. doi: 10.1016/j.ejpb.2011.03.016. Epub 2011 Mar 23.
- Background: PubMed 33580972Auerbach M, Henry D, DeLoughery TG. Intravenous ferric derisomaltose for the treatment of iron deficiency anemia. Am J Hematol. 2021 Jun 1;96(6):727-734. doi: 10.1002/ajh.26124. Epub 2021 Feb 26.
- Background: PubMed 32220343Auerbach M, Gafter-Gvili A, Macdougall IC. Intravenous iron: a framework for changing the management of iron deficiency. Lancet Haematol. 2020 Apr;7(4):e342-e350. doi: 10.1016/S2352-3026(19)30264-9.
- Background: PubMed 34758368Bazeley JW, Wish JB. Recent and Emerging Therapies for Iron Deficiency in Anemia of CKD: A Review. Am J Kidney Dis. 2022 Jun;79(6):868-876. doi: 10.1053/j.ajkd.2021.09.017. Epub 2021 Nov 7.
- Background: PubMed 23252877Cancelo-Hidalgo MJ, Castelo-Branco C, Palacios S, Haya-Palazuelos J, Ciria-Recasens M, Manasanch J, Perez-Edo L. Tolerability of different oral iron supplements: a systematic review. Curr Med Res Opin. 2013 Apr;29(4):291-303. doi: 10.1185/03007995.2012.761599. Epub 2013 Feb 6.
- Background: PubMed 22854645Drueke TB, Parfrey PS. Summary of the KDIGO guideline on anemia and comment: reading between the (guide)line(s). Kidney Int. 2012 Nov;82(9):952-60. doi: 10.1038/ki.2012.270. Epub 2012 Aug 1.
- Background: PubMed 32041774Batchelor EK, Kapitsinou P, Pergola PE, Kovesdy CP, Jalal DI. Iron Deficiency in Chronic Kidney Disease: Updates on Pathophysiology, Diagnosis, and Treatment. J Am Soc Nephrol. 2020 Mar;31(3):456-468. doi: 10.1681/ASN.2019020213. Epub 2020 Feb 10.
- Background: PubMed 21784829Molnar MZ, Mehrotra R, Duong U, Kovesdy CP, Kalantar-Zadeh K. Association of hemoglobin and survival in peritoneal dialysis patients. Clin J Am Soc Nephrol. 2011 Aug;6(8):1973-81. doi: 10.2215/CJN.01050211. Epub 2011 Jul 22.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron isomaltoside and Ferrous succinate in people with Renal Anemia and Peritoneal Dialysis (PD), run by Xie Jingyuan, MD.
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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingyuan Xie (+862164370045 ext. 665272, nephroxie@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in hemoglobin concentration from baseline to week 8 (time frame: Screening period，Day 1，Week 1，Week 4，Week 8). 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 NCT06830941, which also lists 18 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 17 Feb 2025.