Who is sponsoring NCT05704400?

NCT05704400 is sponsored by Istituto Giannina Gaslini.

What drugs are being tested in NCT05704400?

Interventions in NCT05704400: Rituximab Biosimilar ABP 798, Daratumumab.

What condition does NCT05704400 study?

NCT05704400 studies Nephrotic Syndrome.

Is NCT05704400 still recruiting?

NCT05704400 is currently status unknown. Last updated 31 October 2023.

Last reviewed 2023-10-31 · How we verify

NCT05704400

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy of Anti-CD20 Ab Associated With Anti-CD38 in the Childhood Multidrug Dependent and Resistant Nephrotic Syndrome

Status unknown Phase 2 Last updated 31 October 2023

What this trial tests

Phase 2 trial testing Rituximab Biosimilar ABP 798 in Nephrotic Syndrome in 20 participants. Status unknown.

Timeline

1 March 2023

Primary endpoint
1 March 2024

1 March 2025

Quick facts

Lead sponsor	Istituto Giannina Gaslini
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 March 2023
Primary completion	1 March 2024
Estimated completion	1 March 2025
Sites	1 location across Italy

Drugs / interventions tested

Rituximab Biosimilar ABP 798 — full drug profile →
Daratumumab (daratumumab) — full drug profile →

Conditions studied

Nephrotic Syndrome — all drugs for Nephrotic Syndrome →

Sponsor

Istituto Giannina Gaslini — full company profile →

Who can join

Adults 3 to 24, any sex, with Nephrotic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Nephrotic syndrome is considered a disease caused by an interplay of immunological stimuli with adaptive immunity(CD80/CD40) as trigger and Treg in the mid between co-stimulatory molecules and effectors. The positive effect of drugs blocking CD20 maturation in SDNS suggests a main role of these cells in regulating the system. Multidrug dependent, multidrug resistant nephrotic syndrome as well as post transplant FSGS recurrence patients can be considered difficult to treat patients and the association of two drugs, one targeting CD20 and a targeting plasmacells can be use in order to block the stimulatory cascade at more sites.

Publications & conference data

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

Management of adult patients with podocytopathies: an update from the ERA Immunonephrology Working Group.
Mirioglu S, Daniel-Fischer L, Berke I, Ahmad SH, et al · · 2024 · cited 23× · PMID 38341276 · DOI 10.1093/ndt/gfae025
State of the art in childhood nephrotic syndrome: concrete discoveries and unmet needs.
Vincenti F, Angeletti A, Ghiggeri GM. · · 2023 · cited 14× · PMID 37503337 · DOI 10.3389/fimmu.2023.1167741
Biologics in steroid resistant nephrotic syndrome in childhood: review and new hypothesis-driven treatment.
Angeletti A, Bruschi M, Kajana X, La Porta E, et al · · 2023 · cited 12× · PMID 37705972 · DOI 10.3389/fimmu.2023.1213203
Application of CD38 monoclonal antibody in kidney disease.
Chen Z, Xu Q, Shou Z. · · 2024 · cited 6× · PMID 38799465 · DOI 10.3389/fimmu.2024.1382977
Anti-B Cell Strategy in Nephrotic Syndrome: Beyond Rituximab.
Jin Y, Xie Y, Fu H, Liu F, et al · · 2025 · cited 2× · PMID 41007627 · DOI 10.3390/biomedicines13092063
Advances in Focal Segmental Glomerulosclerosis Treatment From the Perspective of the Newest Mechanisms of Podocyte Injury.
Zhu Y, Xu G. · · 2025 · cited 2× · PMID 39935575 · DOI 10.2147/dddt.s498457

Verify or expand the search:

Other recruiting trials for Nephrotic Syndrome

Currently open trials in the same condition.

NCT07214818 — SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome · Phase 2, PHASE3 · active not recruiting
NCT06635720 — REduced-dose Steroid PrOtocol for Childhood Nephrotic SyndromE (RESPONSE) · Phase 3 · recruiting
NCT06622915 — Cardiac Performance Evaluation in Children With Steroid Dependent vs Steroid Resistant Nephrotic Syndrome · NA · recruiting
NCT06161701 — Steroid Diabetes in Patients With Kidney Disease · recruiting
NCT06373913 — The Role of Proprotein-convertase-subtilisin/Kexin-type 9 in Kidney Damage in Nephrotic Syndrom · recruiting

Other Istituto Giannina Gaslini trials

Trials by the same sponsor.

NCT07377630 — Intrathecal MoRphine Versus Transabdominal Plane Block (TAP) Block for AnalGesic Management in Elective Caesarean Sectio · Phase 4 · not yet recruiting
NCT06618937 — Toward Personalized Medicine to Guide Drug Withdrawal in Children with Juvenile Idiopathic Arthritis in Clinical Remissi · Phase 4 · not yet recruiting
NCT06331611 — MONITORING NEUROMUSCULAR BLOCK IN PAEDIATRIC ANAESTHESIA · NA · unknown
NCT05075837 — Adoptive T-cell Therapy for Resistant Viral Infections After Allogeneic HSCT · Phase 1 · unknown
NCT06150404 — A Randomized Controlled Trial to Evaluate the Effect of White Noises and Parental Voices As Protectors Against Noise Dam · NA · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05704400 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Istituto Giannina Gaslini
Last refreshed: 31 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05704400.

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