Primary outcomeCount of participants· 6 Months
Number of Patients With a Complete Response (CR)
| Group | Value (Participants) |
|---|---|
| CellCept Daily & ACTHar Gel BIW (Two Times Per Week) | 2 |
| CellCept Daily & ACTHar Gel TIW (Three Times Per Week) | 0 |
Trial · Interventional
TerminatedPhase 4Results postedRegistry dataACTHar in the Treatment of Lupus Nephritis
Short name ACTHar
NCTNCT02226341 (opens ClinicalTrials.gov in a new tab)Other idAAAN4752
This trial was stopped early.
Reason given at the registry: Lack of funding
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 4
- Enrollment
- 8 participants (actual)
- Sponsor
- Columbia University · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Oct 2014
- Primary completion
- 3 Jan 2024
- Completion
- 3 Jan 2024
- First posted
- 27 Aug 2014 (estimated)
- Last update posted
- 7 Mar 2025
- Conditions
- Lupus Nephritis
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201420162018202020222024
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Systemic Lupus Erythematosus (SLE) is a disease in which the immune system attacks the healthy cells and tissues, causing inflammation that can damage organs in the body. About 50% of SLE patients experience inflammation in the kidneys. The purpose of this study is to determine the effectiveness and safety of two dosing arms of ACTHar gel in treating proliferative Lupus Nephritis (LN). This study hypothesizes that both dosing arms of ACTHar are safe and effective in treating proliferative LN (Class III and IV).
Interventions
- CellCeptDrug
- ACTHar gelDrug
Arms2
Active comparator
CellCept daily & ACTHar gel biw
Patients will be treated with CellCept 3 grams daily and ACTHar gel 80 U biw for 3 months per Aim 1. After 3 months, patients with complete response will stop ACTHar gel but continue CellCept 3 grams daily for another 3 months whereas patients with partial response will continue CellCept 3 grams daily and be offered the option to continue ACTHar 80 U biw for another 3 months. After 6 months, all patients will continue CellCept at a dose of 2 grams daily for another 18 months.
Active comparator
CellCept daily & ACTHar gel qod
Patients will be treated with CellCept 3 grams daily for 3 months, and ACTHar gel 80 U qod for the first month and ACTHar gel 80 U biw for the following 2 months per Aim 2. After 3 months, patients with complete response will stop ACTHar gel but continue CellCept 3 grams daily for another 3 months whereas patients with partial response will continue CellCept 3 grams daily and be offered the option to continue ACTHar 80 U biw for another 3 months. After 6 months, all patients will continue CellCept at a dose of 2 grams daily for another 18 months.
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Patients With a Complete Response (CR)
Time frame · 6 Months
Registry description
Complete response (CR) is defined as all of the following criteria having been achieved: 1. Stabilization of estimated glomerular filtration rate (eGFR) (i.e., a 6-month eGFR level ± 10% of baseline) or improvement if the screening value is changed from patient's baseline 2. Inactive urinary sediment (red blood cells per high-power field \[RBCs/HPF\] \< 5-10, not due to gyn bleeding) 3. Urine protein/creatinine ratio \< 0.5
Secondary outcomes(4)
Number of Responders
Time frame · 6 Months
Registry description
Responders = Complete Responders (CR) + Partial Responders (PR). PR = improvement from baseline of at least ≥ 50% in all abnormal renal parameters (proteinuria and serum creatinine) without deterioration of any measurements at 6 months
Number of Patients With Extra-renal Flares
Time frame · 6 Months
Registry description
Frequency of extra-renal flares as defined by the SELENA-SLEDAI Flare Index. Extra-renal disease activity measured by SELENA-SLEDAI and BILAG
Number of Patients With Steroid -Like Side Effects
Time frame · 6 Months
Registry description
Steroid -like side effects: increase in blood pressure (BP) by 20 mmHg for both systolic blood pressure (SBP) and diastolic blood pressure (DBP), increased blood sugar with a fasting plasma glucose level ≥ 126 mg/dl, weight gain ≥ 10% of the initial weight, infections
Number of Patients With Side Effects
Time frame · 6 Months
Registry description
Number of participants who experienced side effects from taking ACTHar
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeCount of participants· 6 Months
Number of Responders
| Group | Value (Participants) |
|---|---|
| CellCept Daily & ACTHar Gel BIW (Two Times Per Week) | 2 |
| CellCept Daily & ACTHar Gel TIW (Three Times Per Week) | 1 |
Secondary outcomeCount of participants· 6 Months
Number of Patients With Extra-renal Flares
| Group | Value (Participants) |
|---|---|
| CellCept Daily & ACTHar Gel BIW (Two Times Per Week) | 0 |
| CellCept Daily & ACTHar Gel TIW (Three Times Per Week) | 1 |
Secondary outcomeCount of participants· 6 Months
Number of Patients With Steroid -Like Side Effects
| Group | Value (Participants) |
|---|---|
| CellCept Daily & ACTHar Gel BIW (Two Times Per Week) | 0 |
| CellCept Daily & ACTHar Gel TIW (Three Times Per Week) | 0 |
Secondary outcomeCount of participants· 6 Months
Number of Patients With Side Effects
| Group | Value (Participants) |
|---|---|
| CellCept Daily & ACTHar Gel BIW (Two Times Per Week) | 0 |
| CellCept Daily & ACTHar Gel TIW (Three Times Per Week) | 0 |
Other pre specified outcome· Upon study completion, up to 30 months
Mean Urinary Lymphocytes
| Group | Value |
|---|---|
| CellCept Daily & ACTHar Gel BIW (Two Times Per Week) | not posted |
| CellCept Daily & ACTHar Gel TIW (Three Times Per Week) | not posted |
Other pre specified outcome· Upon study completion, up to 30 months
Mean Cortisol Levels
| Group | Value |
|---|---|
| CellCept Daily & ACTHar Gel BIW (Two Times Per Week) | not posted |
| CellCept Daily & ACTHar Gel TIW (Three Times Per Week) | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| CellCept Daily & ACTHar Gel BIW (Two Times Per Week)Patients will be treated with CellCept 3 grams daily and ACTHar gel 80 U BIW for 3 months per Aim 1. After 3 months, patients with complete response will stop ACTHar gel but continue CellCept 3 grams daily for another 3 months whereas patients with partial response will continue CellCept 3 grams daily and be offered the option to continue ACTHar 80 U biw for another 3 months. After 6 months, all patients will continue CellCept at a dose of 2 grams daily for another 18 months. | 0 / 4 | 0 / 4 | 1 / 4 |
| CellCept Daily & ACTHar Gel TIW (Three Times Per Week)Patients will be treated with CellCept 3 grams daily for 3 months, and ACTHar gel 80 U TIW for the first month and ACTHar gel 80 U BIW for the following 2 months per Aim 2. After 3 months, patients with complete response will stop ACTHar gel but continue CellCept 3 grams daily for another 3 months whereas patients with partial response will continue CellCept 3 grams daily and be offered the option to continue ACTHar 80 U BIW for another 3 months. After 6 months, all patients will continue CellCept at a dose of 2 grams daily for another 18 months. | 0 / 4 | 1 / 4 | 0 / 4 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
More studies
1 study on this page
Indexing hint: Clinical trial · 2012
Treatment of resistant glomerular diseases with adrenocorticotropic hormone gel: a prospective trial.
Bomback et al. 2012American journal of nephrologycited by 64
PMID 22722778DOI 10.1159/000339287PUB-22722778
Full text at the publisher
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 16 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR)/SLICC criteria
2. Age ≥ 16 years
3. Active lupus nephritis defined by:
a. Kidney biopsy documentation of International Society of Nephrology/Renal Pathology Society (ISN/RPS) Class III or Class IV proliferative nephritis (including Class V occurring in combination with Class III or IV) within 12 months and a urine protein/creatinine ratio \>1 at time of entry to study
4. Ability to provide informed consent
Exclusion Criteria:
1. Moderately severe anemia (Hgb \< 8 mg/dL)
2. Neutropenia (\< 1,000/mm3)
3. Thrombocytopenia (platelets \< 50,000/mm3)
4. Positive purified protein derivative (PPD) test confirmed by positive Quantiferon TB gold.
5. Pulmonary fibrotic changes on chest radiograph consistent with prior healed tuberculosis
6. Active infections that in the opinion of the investigator increase the risks to the subject.
7. Known human immunodeficiency virus (HIV) and hepatitis B or C
8. End-stage renal disease (estimated GFR clearance \< 20 mL/min/1.73 m2)
9. History of cancer, except carcinoma in situ and treated basal and squamous cell carcinomas
10. Pregnancy
11. Lactation
12. Unwillingness to use a medically acceptable form of birth control (including but not limited to a diaphragm, an intrauterine device, progesterone implants or injections, oral contraceptives, the double-barrier method, or a condom)
13. Previous failure to respond to MMF
14. Use of rituximab within the past year
15. Use of experimental therapeutic agents within the past 60 days
16. Greater than or equal to 5 times the upper limit of normal of liver function tests (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], or alkaline phosphatase)
17. Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease (or, in the investigator's opinion, any other concomitant medical condition that places the participant at risk by participating in this study) with the exception of diseases or conditions related to active SLE
18. Current substance abuse
PepBank is a research reference. Talk to a doctor before you use any peptide.