NCT01359345 (NSF) is a Phase 2/Phase 3 clinical trial of gadollinum in Nephrogenic Systemic Fibrosis, sponsored by Imam Khomeini Hospital.

Who is sponsoring NCT01359345?

NCT01359345 is sponsored by Imam Khomeini Hospital.

What drugs are being tested in NCT01359345?

Interventions in NCT01359345: gadollinum.

What condition does NCT01359345 study?

NCT01359345 studies Nephrogenic Systemic Fibrosis, Renal Failure.

Is NCT01359345 still recruiting?

NCT01359345 is currently status unknown. Last updated 21 June 2012.

Last reviewed 2012-06-21 · How we verify

NCT01359345: NSF

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

The Prevalence and Severity of Nephrogenic Systemic Fibrosis in Patients Whom Underwent Imaging With Gadollinium(MRI/MRA) in University Hospital of Tehran Heart Center in 2003-2008

Status unknown Phase 2/Phase 3 Last updated 21 June 2012

What this trial tests

Phase 2/Phase 3 trial testing gadollinum in Nephrogenic Systemic Fibrosis in 200 participants. Status unknown.

Timeline

1 July 2008

Primary endpoint
1 May 2011

1 August 2012

Quick facts

Lead sponsor	Imam Khomeini Hospital
Phase	Phase 2/Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	200
Start date	1 July 2008
Primary completion	1 May 2011
Estimated completion	1 August 2012
Sites	1 location across Iran

Drugs / interventions tested

gadollinum — full drug profile →

Conditions studied

Nephrogenic Systemic Fibrosis — all drugs for Nephrogenic Systemic Fibrosis →
Renal Failure — all drugs for Renal Failure →

Sponsor

Imam Khomeini Hospital

Who can join

18 and older, any sex, with Nephrogenic Systemic Fibrosis or Renal Failure. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

occurrence of fibrosis
Time frame: after 2 month of exposure with gadollinum

Sponsor's own description

Recently there is increasing reports of NEPHROGENIIC SYSTEMIC FIBROSIS(NSF) in patients with severe renal failure mainly in patients under dialysis in whom gadollinum is being used. The investigators will evaluate the prevalence and severity of NSF in patients with different degree of renal failure whom underwent imaging with Gadolinum.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Advances in Selenium and Related Compounds Inhibiting Multi-Organ Fibrosis.
Xiao X, Huang G, Yu X, Tan Y. · · 2025 · cited 3× · PMID 39830783 · DOI 10.2147/dddt.s488226

Verify or expand the search:

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 NCT01359345 (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 Imam Khomeini Hospital
Last refreshed: 21 June 2012

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/NCT01359345.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing