Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.
The purpose of this phase I/II study ia to establish that dose of NKT-01 which leads to complete response during a minimum of 6 cycles of treatment without causing WHO grade 3 leukopenia (WBC < 2x10^9/L). The patients suffered from uncontrolled lupus nephritis (LN) and took OCS (<= 1.0 mf/kf/day, a maximum dose of 80 mg/day) in addition to NKT-01. Therefore the aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | NKT-01 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NKT-01 | Drug | SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete and Partial Response Rate | A four-point scale was defined: complete response (CR), partial response (PR), stable disease (SD) or treatment failure (TF). The response criteria were defined prior to the start of the study: for a CR, PR or SD prednisone had to be decreased to <= 7.5 mg/day, a higher dosage was automatically classified as TF. The presence of urinary erythrocyte or granular casts excluded CR. As the baseline activity of every patient is different, it was necessary to define baseline proteinuria (g/24 h) or kidney function (estimated glomerular filtration rate) as the reference value for the definition of response for every patient individually. The baseline was defined as the renal function and proteinuria level before the onset of the recent LN flare which qualified the patient for the study. Response was determined as the ratio of the proteinuria or kidney function at cycle 4, 6 or 9 to the baseline values of the individual patient. | Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SELENA-SLEDAI Score | The "Safety of Estrogen in Lupus Erythematosus National Assessment - systemic lupus erythematosus disease activity index' (SELENA-SLEDAI) document the current activity of SLE/LN. It contains 24 items (descriptors), which are differently weighed. The score has a total range of 0 - 105. As a maximum 105 score points can be reached meaning the worst disease activity. | Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hanns-Martin Lorenz, Professor | Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Faculty Hospital | Prague | 12808 | Czechia | |||
| Universitatsklinikum Charite |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21356124 | Derived | Lorenz HM, Schmitt WH, Tesar V, Muller-Ladner U, Tarner I, Hauser IA, Hiepe F, Alexander T, Woehling H, Nemoto K, Heinzel PA. Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin: an open-label dose escalation study. Arthritis Res Ther. 2011 Mar 1;13(2):R36. doi: 10.1186/ar3268. |
Not provided
Not provided
Not provided
The study was conducted at 6 sites in Germany and Czech Republic from 2003 to 2007
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Deoxyspergualin | SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Deoxyspergualin | SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete and Partial Response Rate | A four-point scale was defined: complete response (CR), partial response (PR), stable disease (SD) or treatment failure (TF). The response criteria were defined prior to the start of the study: for a CR, PR or SD prednisone had to be decreased to <= 7.5 mg/day, a higher dosage was automatically classified as TF. The presence of urinary erythrocyte or granular casts excluded CR. As the baseline activity of every patient is different, it was necessary to define baseline proteinuria (g/24 h) or kidney function (estimated glomerular filtration rate) as the reference value for the definition of response for every patient individually. The baseline was defined as the renal function and proteinuria level before the onset of the recent LN flare which qualified the patient for the study. Response was determined as the ratio of the proteinuria or kidney function at cycle 4, 6 or 9 to the baseline values of the individual patient. | ITT population | Posted | Number | Percentage of participants | Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks |
|
Throughout study period, up to 27 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deoxyspergualin | SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cyclophosphamide induced leucopenia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pharmaceuticals Group | Nippon Kayaku Co., Ltd. | +81-3-6731-5200 |
Not provided
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C037258 | gusperimus |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Treatment Days With Corticosteroids of <= 7.5 mg/Day | Entry to the study was permitted for patients with doses of oral corticosteroids (OCS) of <= 1.0 mg/kg/day (maximum dose 80 mg/day). OCS dosage was maintained, decreased or increased according to the response to DSG. The number of days on which the OCS dose was <= 7.5 mg/day was counted in each cycle. | 1st and 9th Cycle |
| Berlin |
| 10117 |
| Germany |
| Universitat Frankfurt | Frankfurt | 60590 | Germany |
| University of Heidelberg | Heidelberg | 69120 | Germany |
| University Hospital Mannheim, Heidelberg University | Mannheim | 68135 | Germany |
| University of Regensburg | Regensburg | Germany |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 | Deoxyspergualin | SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles |
|
|
| Secondary | SELENA-SLEDAI Score | The "Safety of Estrogen in Lupus Erythematosus National Assessment - systemic lupus erythematosus disease activity index' (SELENA-SLEDAI) document the current activity of SLE/LN. It contains 24 items (descriptors), which are differently weighed. The score has a total range of 0 - 105. As a maximum 105 score points can be reached meaning the worst disease activity. | ITT population | Posted | Mean | Full Range | Score on a scale | Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks |
|
|
|
| Secondary | Treatment Days With Corticosteroids of <= 7.5 mg/Day | Entry to the study was permitted for patients with doses of oral corticosteroids (OCS) of <= 1.0 mg/kg/day (maximum dose 80 mg/day). OCS dosage was maintained, decreased or increased according to the response to DSG. The number of days on which the OCS dose was <= 7.5 mg/day was counted in each cycle. | ITT population | Posted | Mean | Full Range | Days | 1st and 9th Cycle |
|
|
|
| 8 |
| 21 |
| 21 |
| 21 |
| Leucopenia | Blood and lymphatic system disorders |
|
| Angina pectris | Cardiac disorders |
|
| Fever | General disorders |
|
| Herpes zoster | Infections and infestations |
|
| Oral candidiasis | Infections and infestations |
|
| Parodontitis, tooth infection, fever | Infections and infestations |
|
| Pneumonia | Infections and infestations |
|
| Increase in serum creatinine (renal failure) | Investigations |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
| Increased lupus activity with increased proteinuria and pain | Renal and urinary disorders |
|
| Lupus flare (arthritis, myalgia, skin rash) | Renal and urinary disorders |
|
| Renal failure (Severe proteinuria) | Renal and urinary disorders |
|
| Excision of an uterine myoma | Surgical and medical procedures |
|
| Hospitalization for a second cyclophosphamide pulse | Surgical and medical procedures |
|
| Oral candidiasis | Infections and infestations |
|
| Vaginal candidiasis | Infections and infestations |
|
| Nasopharyngitis | Infections and infestations |
|
| Respiratory tract infection | Infections and infestations |
|
| Bronchitis | Infections and infestations |
|
| Pneumonia | Infections and infestations |
|
| Herpes simplex | Infections and infestations |
|
| Herpes zoster | Infections and infestations |
|
| Dental caries | Infections and infestations |
|
| Fungal skin infection | Infections and infestations |
|
| Gasteroenteritis | Infections and infestations |
|
| Infected insect bite | Infections and infestations |
|
| Labyrinthitis | Infections and infestations |
|
| Onychomycosis | Infections and infestations |
|
| Otitis media | Infections and infestations |
|
| Pharyngitis | Infections and infestations |
|
| Rhinitis | Infections and infestations |
|
| Sialoadentitis | Infections and infestations |
|
| Tinea infection | Infections and infestations |
|
| Tonsillitis | Infections and infestations |
|
| Tooth infection | Infections and infestations |
|
Not provided
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| The last day of Cycle 9 |
|