Trial · NCT03643965
Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy
NCT03643965, Phase 3, Completed, Asahi Kasei Therapeutics, AB; results first posted 2024-12-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy. Trials, record NCT03643965. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03643965
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy
- NCT number
- NCT03643965
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 365 participants, actual
- Lead sponsor
- Asahi Kasei Therapeutics, AB
- Conditions
- Primary IgA Nephropathy
- Interventions
- Nefecon, Placebo oral capsule
- First posted
- 2018-08-23
- Last updated
- 2024-12-03
- Results first posted
- 2024-12-03
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Ratio of Urine Protein to Creatinine Ratio (UPCR) at 9 Months Compared to Baseline | 9 months | Part A primary endpoint: The ratio of Urine Protein to Creatinine Ratio (UPCR) (based on 24-hour urine collections) at 9 months following the first dose of study drug compared to baseline. Ratio being: UPCR at 9 months in g/gram divided with UPCR at Baseline in g/gram |
| Primary | Part B: Time-weighted Average of Estimated Glomerular Filtration Rate (eGFR) | Up to 2 years and 1 month | Part B Primary endpoint: Time-weighted average of estimated glomerular filtration rate (eGFR) recordings observed at each time point over 2 years. The eGFR (CKD-EPI) at 2 years (which must have been repeated to provide a second value obtained within 14 to 35 days) was the geometric mean of the 2 assessments. |
| Secondary | Part A: Ratio of eGFR at 9 Months | 9 months | Part A: Ratio of eGFR at 9 months compared to baseline calculated using the CKD-EPI formula. |
| Secondary | Part A: Ratio of eGFR at 12 Months | 12 months | Part A: Ratio of eGFR at 12 months compared to baseline calculated using the CKD-EPI formula. |
| Secondary | Part A: Ratio of Urine Albumin to Creatinine Ratio (UACR) at 9 Months | 9 months | Part A: Ratio of urine albumin to creatinine ratio (UACR) at 9 months compared to baseline. |
| Secondary | Part B: Time to 30% Reduction in eGFR | Over 2 years | Part B: Time to 30% reduction from baseline in eGFR (CKD-EPI) confirmed by a second value. For clarity: Please note that the number of patients with a 30% reduction is presented with statistical analysis of the time to 30% reduction. |
| Secondary | Part B: Time to Receiving Rescue Medication. | Over 2 years | Part B: Time from the first dose of study drug until receiving rescue medication. For clarity: Please note that the number of patients receiving rescue medication is presented with statistical analysis of the time to receiving rescue medication. |
| Secondary | Part B: Ratio of UPCR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months | 12, 18 and 24 months | Part B: Ratio of UPCR, UACR, and eGFR (CKD-EPI) compared to baseline averaged over time points between 12 and 24 months, inclusive, following the first dose of study drug |
| Secondary | Part B: Ratio of UACR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months | 12 to 24 months | Part B: Ratio of UPCR, UACR, and eGFR (CKD-EPI) compared to baseline averaged over time points between 12 and 24 months, inclusive, following the first dose of study drug. |
| Secondary | Part B: Ratio of eGFR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months | 12 to 24 months | Part B: Ratio of UPCR, UACR, and eGFR (CKD-EPI) compared to baseline averaged over time points between 12 and 24 months, inclusive, following the first dose of study drug; |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Ratio of Urine Protein to Creatinine Ratio (UPCR) at 9 Months Compared to Baseline | 9 months | Full analysis set - global study - Part A | ratio | GEOMETRIC_LEAST_SQUARES_MEAN |
| PRIMARY | Part B: Time-weighted Average of Estimated Glomerular Filtration Rate (eGFR) | Up to 2 years and 1 month | Full analysis set - global study - Part B | mL/min/1.73m2 | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Ratio of eGFR at 9 Months | 9 months | Full analysis set - global study - Part A | mL/min/1.73m2 | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Ratio of eGFR at 12 Months | 12 months | Full analysis set - global study - Part A | mL/min/1.73m2 | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Ratio of Urine Albumin to Creatinine Ratio (UACR) at 9 Months | 9 months | Full analysis set - global study - Part A | g/gram | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Part B: Time to 30% Reduction in eGFR | Over 2 years | Full analysis set - global study - Part B | Participants | NUMBER |
| SECONDARY | Part B: Time to Receiving Rescue Medication. | Over 2 years | Full analysis set - global study - Part B | Participants | NUMBER |
| SECONDARY | Part B: Ratio of UPCR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months | 12, 18 and 24 months | Full analysis set - global study - Part B | g/gram | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Part B: Ratio of UACR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months | 12 to 24 months | Full analysis set - global study - Part B | g/gram | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Part B: Ratio of eGFR Compared to Baseline Averaged Over Time Points Between 12 and 24 Months | 12 to 24 months | Full analysis set - global study - Part B | mL/min/1.73m2 | GEOMETRIC_LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Ratio of Urine Protein to Creatinine Ratio (UPCR) at 9 Months Compared to Baseline | Nefecon | 0.69 | 96% Confidence Interval 0.61 to 0.79 | ratio | |
| Part A: Ratio of Urine Protein to Creatinine Ratio (UPCR) at 9 Months Compared to Baseline | Placebo Oral Capsule | 0.95 | 96% Confidence Interval 0.83 to 1.08 | ratio | |
| Part B: Time-weighted Average of Estimated Glomerular Filtration Rate (eGFR) | Nefecon | 0.96 | 95% Confidence Interval 0.93 to 0.98 | mL/min/1.73m2 | |
| Part B: Time-weighted Average of Estimated Glomerular Filtration Rate (eGFR) | Placebo Oral Capsule | 0.87 | 95% Confidence Interval 0.84 to 0.89 | mL/min/1.73m2 | |
| Part A: Ratio of eGFR at 9 Months | Nefecon | 1.00 | 95% Confidence Interval 0.96 to 1.03 | mL/min/1.73m2 | |
| Part A: Ratio of eGFR at 9 Months | Placebo Oral Capsule | 0.93 | 95% Confidence Interval 0.90 to 0.96 | mL/min/1.73m2 | |
| Part A: Ratio of eGFR at 12 Months | Nefecon | 0.97 | 95% Confidence Interval 0.93 to 1.01 | mL/min/1.73m2 | |
| Part A: Ratio of eGFR at 12 Months | Placebo Oral Capsule | 0.91 | 95% Confidence Interval 0.88 to 0.95 | mL/min/1.73m2 | |
| Part A: Ratio of Urine Albumin to Creatinine Ratio (UACR) at 9 Months | Nefecon | 0.64 | 95% Confidence Interval 0.55 to 0.75 | g/gram | |
| Part A: Ratio of Urine Albumin to Creatinine Ratio (UACR) at 9 Months | Placebo Oral Capsule | 0.93 | 95% Confidence Interval 0.80 to 1.09 | g/gram |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | Nefecon | 182 | |
| Part A | STARTED | Placebo Oral Capsule | 182 | |
| Part A | COMPLETED | Nefecon | 175 | |
| Part A | COMPLETED | Placebo Oral Capsule | 174 | |
| Part A | NOT COMPLETED | Nefecon | 7 | |
| Part A | NOT COMPLETED | Placebo Oral Capsule | 8 | |
| Part B | STARTED | Nefecon | 175 | |
| Part B | STARTED | Placebo Oral Capsule | 174 | |
| Part B | COMPLETED | Nefecon | 161 | |
| Part B | COMPLETED | Placebo Oral Capsule | 165 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events88
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Edema peripheral | General disorders | Nefecon | 28 | 182 | |
| other | Edema peripheral | General disorders | Placebo Oral Capsule | 7 | 182 | |
| other | Hypertension | Vascular disorders | Nefecon | 21 | 182 | |
| other | Hypertension | Vascular disorders | Placebo Oral Capsule | 6 | 182 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Nefecon | 22 | 182 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Placebo Oral Capsule | 7 | 182 | |
| other | Acne | Skin and subcutaneous tissue disorders | Nefecon | 20 | 182 | |
| other | Acne | Skin and subcutaneous tissue disorders | Placebo Oral Capsule | 2 | 182 | |
| other | Nasopharyngitis | Infections and infestations | Nefecon | 17 | 182 | |
| other | Nasopharyngitis | Infections and infestations | Placebo Oral Capsule | 19 | 182 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nefecon | 1 | 182 |
| Total, all-cause mortality | Placebo Oral Capsule | 0 | 182 |
| Total, other adverse events | Nefecon | 108 | 182 |
| Total, other adverse events | Placebo Oral Capsule | 69 | 182 |
| Total, serious adverse events | Nefecon | 18 | 182 |
| Total, serious adverse events | Placebo Oral Capsule | 9 | 182 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nefecon vs Placebo Oral Capsule: Part B: Proportion of Patients Without Microhematuria | Trial comparisons |
| Nefecon vs Placebo Oral Capsule: Part B: Time to 30% Reduction in eGFR | Trial comparisons |
| Nefecon vs Placebo Oral Capsule: Part B: Time to Receiving Rescue Medication. | Trial comparisons |
| Nefecon vs Placebo Oral Capsule: deaths from any cause | Trial comparisons |
| Nefecon vs Placebo Oral Capsule: serious adverse events | Trial comparisons |
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/NCT03643965
GET https://conductscience.org/api/trials/v1/NCT03643965/results?page=2