CHRONIC HYPONATREMIAPhase 2NCT06798675
Phase 2a Study for PK/PD of nC-001
A Phase 2 study testing nC-001 in people with CHRONIC HYPONATREMIA, run by nephCentric.
Trial summary
CHRONIC EUVOLEMIC HYPONATREMIA Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- CHRONIC HYPONATREMIA
- What is being tested?
- nC-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women ≥18 and ≤85 years of age
- Diagnosis of chronic euvolemic hyponatremia
Who cannot join
- 1. Hyponatremia assessed by the Investigator to be hypervolemic, hypovolemic, or due to psychogenic polydipsia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Priti Kaur contact
About this study
Official title: A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING CLINICAL TRIAL TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF nC-001 IN PATIENTS WITH CHRONIC EUVOLEMIC HYPONATREMIA
CHRONIC EUVOLEMIC HYPONATREMIA
- Conditions
- CHRONIC HYPONATREMIA
- Being tested
- nC-001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nC-001Drug
solid dosage form single dose
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 15gm | Active comparator | Not described Receives: Drug: nC-001 |
| 30gm | Active comparator | Not described Receives: Drug: nC-001 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Urea and Sodium (Na)
Measured: 24 hrs
Secondary outcomes (2)
Safety
Incidence and severity of treatment-emergent adverse events (TEAE) as assessed by CTCAE v5.0
Measured: 15 days
Tolerability
Five-Point Palatability Scale; (scores 1-5)
- Very Bad
- Bad
- Neutral
- Good
- Very Good
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study startAug 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHRONIC HYPONATREMIAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- nephCentric
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798675
- Sponsor's protocol ID
- PNC-101
- Status last verified
- May 2025
- First submitted
- 7 Jan 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING CLINICAL TRIAL TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF nC-001 IN PATIENTS WITH CHRONIC EUVOLEMIC HYPONATREMIA
- ClinicalTrials.gov ID
- NCT06798675
- Acronym / sponsor ID
- PNC-101
- Conditions
- CHRONIC HYPONATREMIA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- nephCentricIndustry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CHRONIC EUVOLEMIC HYPONATREMIA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15gm | Active comparator | Drug: nC-001 |
| 30gm | Active comparator | Drug: nC-001 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women ≥18 and ≤85 years of age
- Diagnosis of chronic euvolemic hyponatremia
Key exclusion criteria (1 listed)
- 1. Hyponatremia assessed by the Investigator to be hypervolemic, hypovolemic, or due to psychogenic polydipsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nC-001solid dosage form single dose | Drug | 15gm, 30gm |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Serum Urea and Sodium (Na)
Time frame: 24 hrs
2 secondary outcomes
Safety
Time frame: 15 days
Tolerability
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Priti Kaur contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nC-001 in people with CHRONIC HYPONATREMIA, run by nephCentric.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Priti Kaur (480-287-1610), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Urea and Sodium (Na) (time frame: 24 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.