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Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol
Plain-language guide to NCT00390624: phase 2 non-randomized trial of ANP (Atrial Natriuretic Peptide), 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00390624
- Phase
- phase 2
- Status
- completed
- Start
- 2003-07
- Completion (planned or actual)
- 2006-12
- Participants
- 20 (estimated)
- Design
- non-randomized, open label (everyone knows who gets what), prevention
- Conditions studied
- Renal Dysfunction; Acute Renal Failure; Mortality
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested ANP (Atrial Natriuretic Peptide).
The researchers intend to treat twenty consecutive allogeneic bone marrow transplant patients in a phase II study comparing results with historical controls.
The registry classes the interventions as drug.
Who Took Part
The registry lists 20 planned participants were the target.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age 18-65 years.
The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: known hypersensitivity to anp or mannitol; congestive heart failure; previous bone marrow transplant.
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
Nothing was hidden in this open-label ANP (Atrial Natriuretic Peptide) study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2003-07 with completion listed for 2006-12.
It ran at 1 site in United States.
Its stated primary purpose is prevention.
What Was Measured
Researchers chose this as the main measure: Renal function will be assessed for first 30 days after transplantation for the primary endpoint. The primary endpoints will be a comparison of the grades of renal dysfunction, incidence of ARF requiring dialysis, and overall survival.
It also tracked 1 secondary outcome, for example Patient will be followed at 3 month intervals for the first year and then yearly for life.
What This Means in Plain Language
Put simply, this is a phase 2, non-randomized trial of ANP (Atrial Natriuretic Peptide) in 20 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the ANP (Atrial Natriuretic Peptide) compound page, all human trials.
Our Notes on the Compound
ANP (Atrial Natriuretic Peptide): A 28-amino-acid heart hormone that relaxes blood vessels and increases salt excretion; carperitide is a recombinant form.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.