Renal ImpairmentsPhase 1NCT07445906
A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment
A Phase 1 study testing RG002C0106 in people with Renal Impairments and IgA Nephropathy (IgAN), run by Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd. at 1 site in China.
Trial summary
This is a Phase I trial designed to evaluate the impact of renal impairment on the efficacy and safety of the drug by comparing pharmacokinetic (PK) parameters and pharmacodynamic (PD) markers after a single subcutaneous injection of RG002C0106 between trial participants with normal renal function and those with mild… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairments, IgA Nephropathy (IgAN)
- What is being tested?
- RG002C0106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2026to 1 Dec 2026
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have been fully informed about the study, volunteered to participate, and provided written informed consent.
- Male or female participants aged 18-60 years (inclusive) at screening.
- Body mass index (BMI) of 19.0-32.0 kg/m² (inclusive) at screening; body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants.
- Absolute estimated glomerular filtration rate (eGFR), calculated using the CKD-EPI 2021 equation during the screening period, falls into the corresponding group as follows:
- Normal renal function: absolute eGFR ≥ 90 mL/min; Mild renal impairment: 60 mL/min ≤ absolute eGFR < 90 mL/min; Moderate renal impairment: 30 mL/min ≤ absolute eGFR < 60 mL/min.
- Female participants of childbearing potential must have a negative serum pregnancy test during the screening period. Highly effective contraception must be used from signing the informed consent form until 6 months after the last dose of the study drug, by the participant and their partner of childbearing potential.
Who cannot join
- At screening, chest radiography demonstrates clinically significant abnormalities.
- Any of the following abnormal laboratory test results at screening:
- Total bilirubin > 1.5 × upper limit of normal (ULN); ALT or AST > 2 × ULN; International normalized ratio (INR) > 2 or any clinically significant abnormality; QTcF ≥ 450 ms in males or QTcF ≥ 470 ms in females (QTc interval must be heart rate-corrected using the Fridericia formula); Other abnormal laboratory test results deemed clinically significant by the investigator.
- Positive test results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at screening.
- Participants with primary or secondary IgA nephropathy (patients with IgA nephropathy are advised to be screened for the Phase IIa study of the investigational product).
- Current diagnosis of tuberculosis (TB); history of active TB with cure < 5 years prior to screening; or high likelihood of TB infection as judged by the investigator based on comprehensive TB screening during the screening period.
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- Presence or suspected presence of other active viral, bacterial, fungal, or parasitic infections within 4 weeks before screening.
- History of epidemic meningococcal infection, or other recurrent or chronic infections.
- History of splenectomy or asplenia.
- History of complement abnormalities or hereditary complement deficiency.
- Development of acute kidney injury within 2 weeks before screening.
- History of renal transplantation, or requirement for renal dialysis during the study.
Trial locations and contacts
1 site in 1 country.
China1 site
No. 50 in Huatuo Road, Daxing District
Beijing, Beijing Municipality, 102600
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, PK and PD of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment
This is a Phase I trial designed to evaluate the impact of renal impairment on the efficacy and safety of the drug by comparing pharmacokinetic (PK) parameters and pharmacodynamic (PD) markers after a single subcutaneous injection of RG002C0106 between trial participants with normal renal function and those with mild to moderate renal impairment.
- Conditions
- Renal Impairments, IgA Nephropathy (IgAN)
- Being tested
- RG002C0106
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RG002C0106Drug
Subcutaneous (SC) single dose 200mg
| Study group | Role | What they receive |
|---|---|---|
| RG002C0106 Injection | Experimental | Not described Receives: Drug: RG002C0106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculate the pharmacokinetic (PK) parameters:Cmax
Measured: From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:Tmax
Measured: From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:AUC0-12h , AUC0-24h , AUC0-t, AUC0-∞
Measured: From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:t½
Measured: From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:Vd/F
Measured: From enrollment to the end of treatment at 4 days
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug.
Measured: up to 169 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start15 Mar 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentsStudies 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445906
- Sponsor's protocol ID
- RG002C0106-102
- Status last verified
- Aug 2026
- First submitted
- 11 Feb 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, PK and PD of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment
- ClinicalTrials.gov ID
- NCT07445906
- Acronym / sponsor ID
- RG002C0106-102
- Conditions
- Renal Impairments, IgA Nephropathy (IgAN)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Mar 2026 (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.
This is a Phase I trial designed to evaluate the impact of renal impairment on the efficacy and safety of the drug by comparing pharmacokinetic (PK) parameters and pharmacodynamic (PD) markers after a single subcutaneous injection of RG002C0106 between trial participants with normal renal function and those with mild to moderate renal impairment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RG002C0106 Injection | Experimental | Drug: RG002C0106 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Have been fully informed about the study, volunteered to participate, and provided written informed consent.
- Male or female participants aged 18-60 years (inclusive) at screening.
- Body mass index (BMI) of 19.0-32.0 kg/m² (inclusive) at screening; body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants.
- Absolute estimated glomerular filtration rate (eGFR), calculated using the CKD-EPI 2021 equation during the screening period, falls into the corresponding group as follows:
- Normal renal function: absolute eGFR ≥ 90 mL/min; Mild renal impairment: 60 mL/min ≤ absolute eGFR < 90 mL/min; Moderate renal impairment: 30 mL/min ≤ absolute eGFR < 60 mL/min.
Key exclusion criteria (12 listed)
- At screening, chest radiography demonstrates clinically significant abnormalities.
- Any of the following abnormal laboratory test results at screening:
- Total bilirubin > 1.5 × upper limit of normal (ULN); ALT or AST > 2 × ULN; International normalized ratio (INR) > 2 or any clinically significant abnormality; QTcF ≥ 450 ms in males or QTcF ≥ 470 ms in females (QTc interval must be heart rate-corrected using the Fridericia formula); Other abnormal laboratory test results deemed clinically significant by the investigator.
- Positive test results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at screening.
- Participants with primary or secondary IgA nephropathy (patients with IgA nephropathy are advised to be screened for the Phase IIa study of the investigational product).
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 |
|---|---|---|
| RG002C0106Subcutaneous (SC) single dose 200mg | Drug | RG002C0106 Injection |
Primary outcome
Calculate the pharmacokinetic (PK) parameters:Cmax
Time frame: From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:Tmax
Time frame: From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:AUC0-12h , AUC0-24h , AUC0-t, AUC0-∞
Time frame: From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:t½
Time frame: From enrollment to the end of treatment at 4 days
Calculate the pharmacokinetic (PK) parameters:Vd/F
Time frame: From enrollment to the end of treatment at 4 days
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug.
Time frame: up to 169 days
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 15 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RG002C0106 in people with Renal Impairments and IgA Nephropathy (IgAN), run by Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd. at 1 site in China.
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 6 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculate the pharmacokinetic (PK) parameters:Cmax (time frame: From enrollment to the end of treatment at 4 days). The study lists 6 primary outcomes in all. 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 15 Oct 2026.