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TP10 Use in Patients With C3 Glomerulopathy (C3G)

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ClinicalTrials.gov Identifier: NCT02302755
Recruitment Status : Withdrawn (no recruitment)
First Posted : November 27, 2014
Last Update Posted : October 27, 2016
Information provided by (Responsible Party):
Richard JH Smith, University of Iowa

Brief Summary:
The purpose of this study is to evaluate the safety of repeated TP10 dosing in pediatric and adult patients with C3G and to evaluate the activity of TP10 in pediatric and adult patients with C3G, as measured by the proportion of patients with normalization of serum C3, serum C3 breakdown products, or alternative pathway (AP) complement activity.

Condition or disease Intervention/treatment Phase
Dense Deposit Disease Drug: TP10 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot, Open-Label Single Center Trial of TP10 in Pediatric and Adult Patients With C3 Glomerulopathy (C3G)
Study Start Date : November 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Screening/ Active Treatment Arm

Screening Period: This includes diagnosis confirmation, consent, required tests and vaccinations.

Treatment Period: All patients will be enrolled through the University of Iowa. This study will follow a patient-specific TP10 dose-escalation scheme during the Induction Period and subsequent dose adjustments based on complement levels during the Maintenance Period

Drug: TP10
All patients will be enrolled through the University of Iowa. This study will follow a patient-specific dose-escalation scheme during the Induction Period and subsequent TP10 dose adjustments based on complement levels during the Maintenance Period.
Other Name: sCR1

Primary Outcome Measures :
  1. C3 serum measurements, serum C3 breakdown products, and/or alternative pathway (AP) complement activity. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Appropriate dose range and regimen for TP10. [ Time Frame: 2 years ]
    This will be based on biologic parameters including serum levels of C3 and C3 breakdown products, assays of alternative pathway activity, and dose-limiting toxicities.

Other Outcome Measures:
  1. Immunogenicity of repeat TP10 administration. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient must have C3G as confirmed by renal biopsy within six months of enrollment (confirmation by University of Iowa investigators is required). If the patient is post transplant, the repeat renal transplant biopsy must show C3 dominant glomerulonephritis, and the patient must have a history of known C3G in the native kidney.
  2. C3 serum must be less than 75% of the lower limit of normal.
  3. Signs of alternative pathway dysregulation must be present. C3 breakdown products or C3Nef activity must be detectable in plasma using assays described and validated at the University of Iowa
  4. Serum creatinine level must be abnormal (>97 percentile for age or <80 ml/min using the Cockroft Gault equation for adults).
  5. Must have either 24 hour urine protein >1000 mg/day, or urine protein:creatinine ratio >1.0.
  6. Screening laboratory values must meet the following criteria:

    • hemoglobin ≥ 9.0 g/dL
    • platelet count ≥ 100,000/mm3
    • alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3.0 x ULN
  7. Must use adequate birth control measures.
  8. Patient must be willing and able to comply with study procedures including vaccination against meningitis, haemophilus and pneumococci at least 2 weeks prior to starting the Induction Period and agree to a renal biopsy at the conclusion of the study.
  9. Any anti-proteinuric medications (eg, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers) must be at a stable dose for at least four weeks prior to first dose of TP10.

Exclusion Criteria:

  1. Dialysis or patients with an estimated glomerular filtration rate (eGFR; using Cockroft Gault equation) of less than 30 ml/min/1.73 m2 for over a four-week period prior to the Screening Period
  2. Presence or suspicion of active or untreated systemic bacterial infection that in the opinion of the investigator precludes treatment with TP10
  3. Pregnancy or lactation
  4. Rituximab therapy, unless discontinued with B cell levels and immunoglobulin levels normalized by study entry
  5. Patients receiving immunosuppressive therapies (except for low dose steroids [≤10 mg of prednisone or equivalent per day] given for non-C3G related conditions such as asthma). Patients receiving steroids for C3G must complete a taper prior to study entry. Exceptions will be made for renal transplant patients, who may receive any appropriate therapies as needed to maintain the transplant (i.e., to prevent rejection).
  6. Receipt of any complement inhibitor within 2 months of study entry
  7. Receipt of any other investigational drug or device or experimental procedures beginning four weeks prior to study enrollment
  8. For renal transplant patients only: histology findings of treatable rejection (i.e. that the usual transplant physician would seek to treat). Chronic allograft nephropathy is not exclusionary provided the patient's GFR meets other entry criteria.
  9. A preexisting condition with a reported association as a potential cause of C3G (i.e., Monoclonal Gammopathy of Undetermined Significance [MGUS]) or an alternate glomerular disease that may interfere with the interpretation of study results
  10. Malignancy except for adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the patient has been disease-free for ≥ 5 years
  11. Patients with myocardial infarction (MI) within 1 year of screening, congestive heart failure, arrhythmia persistent on medication at screening or clinically evident chronic lung disease
  12. Known Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection
  13. Any medical or psychological condition that, in the opinion of the investigator, would increase the patient's risk by participation in this study or would interfere with interpretation of the study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302755

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United States, Iowa
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
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Principal Investigator: Richard JH Smith, MD University of Iowa
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Responsible Party: Richard JH Smith, MD (Principal Investigator), University of Iowa
ClinicalTrials.gov Identifier: NCT02302755    
Other Study ID Numbers: UIowa
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Glomerulonephritis, Membranoproliferative
Kidney Diseases
Urologic Diseases
Immune System Diseases