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NCT03168906: RAIN
Renal AL Amyloid Involvement and NEOD001
Phase 2 trial testing NEOD001 in Amyloidosis in 12 participants. Terminated before completion.
23 April 2018
Quick facts
| Lead sponsor | Tufts Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 5 July 2017 |
| Primary completion | 23 April 2018 |
| Estimated completion | 6 February 2019 |
| Sites | 9 locations across United States |
Drugs / interventions tested
- NEOD001 — full drug profile →
- Placebo
Conditions studied
- Amyloidosis — all drugs for Amyloidosis →
Sponsor
Tufts Medical Center
Who can join
18 and older, any sex, with Amyloidosis. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Other adverse events (10 terms — click to expand)
| Reaction | System | NEOD001 | Placebo |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Chest pain | General disorders | — | — |
| Left arm pain | Nervous system disorders | — | — |
| Right hip pain | Musculoskeletal and connective tissue disorders | — | — |
| Concussion | Injury, poisoning and procedural complications | — | — |
| Dysuria | Renal and urinary disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Upper and lower extremity swelling | General disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Coughing spells | Respiratory, thoracic and mediastinal disorders | — | — |
Data from ClinicalTrials.gov NCT03168906 adverse events section.
Sponsor's own description
This is a multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who have a maintained hematologic response to their most recent treatment for AL amyloidosis (e.g., chemotherapy, autologous stem cell transplant \[ASCT\]) and have persistent renal dysfunction.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Treating Protein Misfolding Diseases: Therapeutic Successes Against Systemic Amyloidoses.
Nevone A, Merlini G, Nuvolone M. · · 2020 · cited 26× · PMID 32754033 · DOI 10.3389/fphar.2020.01024 -
Systemic AL amyloidosis: current approach and future direction.
Bou Zerdan M, Nasr L, Khalid F, Allam S, et al · · 2023 · cited 25× · PMID 37185672 · DOI 10.18632/oncotarget.28415 -
Novel Therapies in Light Chain Amyloidosis.
Milani P, Merlini G, Palladini G. · · 2018 · cited 12× · PMID 29854961 · DOI 10.1016/j.ekir.2017.11.017 -
Gene Expression Sets and Renal Profiling from the Renal AL Amyloid Involvement and NEOD00 (RAIN) Trial.
Varga C, Eichinger F, Nair V, Naik AS, et al · · 2024 · PMID 39291193 · DOI 10.1016/j.ekir.2024.07.002
Verify or expand the search:
- PubMed search for NCT03168906
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of NEOD001
Trials testing the same drug.
- NCT03154047 — Study in Subjects With Light Chain (AL) Amyloidosis · Phase 2 · terminated
Other recruiting trials for Amyloidosis
Currently open trials in the same condition.
- NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
- NCT06974877 — Repeat PET/CT Imaging in People With CAPS and Anakinra-Induced Amyloidosis Using an Amyloid-Reactive Peptide to Measure · Phase 1 · recruiting
- NCT07081646 — A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloido · Phase 1, PHASE2 · recruiting
- NCT07232459 — [18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis · recruiting
- NCT06573723 — Institutional Registry of Rare Diseases · recruiting
Other Tufts Medical Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03168906 (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 Tufts Medical Center
- Last refreshed: 9 September 2020
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/NCT03168906.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing