Trial · NCT04580420
Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD
NCT04580420, Phase 2, Recruiting, Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD. Trials, record NCT04580420. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04580420
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD
- NCT number
- NCT04580420
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 28 participants, estimated
- Lead sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
- Conditions
- Primary Hyperoxaluria Type 1, End Stage Renal Disease
- Interventions
- DCR-PHXC
- First posted
- 2020-10-08
- Last updated
- 2025-12-24
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety: Incidence of Events | 180 days | To assess the efficacy of DCR-PHXC in lowering Pox in participants with PH1 and severe renal impairment, with or without hemodialysis or peritoneal dialysis. |
| Primary | Safety: Incidence of Events | 180 days | Characterize the safety of DCR-PHXC in participants with PH1 and severe renal impairment, with or without dialysis. |
| Secondary | Change from Baseline in Plasma Oxalate Concentration | 180 Days | To evaluate the effect of DCR-PHXC on Plasma Oxalate concentration from Baseline to day 180 |
| Secondary | To characterize the PK of DCR PHXC in patients with PH by observing secondary parameters of the area under the curve. | 180 days | Population and individual pharmacokinetic (PK) parameters for DCR PHXC, including secondary parameters of area under the curve (AUC) |
| Secondary | To characterize the PK of DCR PHXC in patients with PH by observing maximum observed concentration (Cmax). | 180 days | Population and individual pharmacokinetic (PK) parameters for DCR PHXC, including maximum observed concentration (Cmax) |
| Secondary | To characterize the PK of DCR PHXC in patients with PH by observing minimum concentration (Cmin). | 180 days | Population and individual pharmacokinetic (PK) parameters for DCR PHXC, including minimum observed concentration (Cmin) |
| Secondary | To characterize the PK of DCR PHXC in patients with PH by observing maximum concentration (Tmax). | 180 days | Population and individual pharmacokinetic (PK) parameters for DCR PHXC, including time to maximum concentration (Tmax) |
| Secondary | To characterize the PK of DCR PHXC in patients with PH by observing terminal elimination half-life (t1/2). | 180 days | Population and individual pharmacokinetic (PK) parameters for DCR PHXC, including terminal elimination half-life (t1/2) |
| Secondary | Change in Frequency of Dialysis | 180 days | Change from Baseline in the frequency of dialysis over 180 days |
| Secondary | Change in Duration of Dialysis | 180 days | Change from Baseline in the duration of dialysis over 180 days |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40193200 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04580420
GET https://conductscience.org/api/trials/v1/NCT04580420/registered