Kidney FailurePhase 1NCT03791476
RUCONEST® as a Therapeutic Strategy to Reduce the Incidence of Delayed Graft Function
A Phase 1 study testing rhC1INH and Saline Solution in people with Kidney Failure, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
An unmet medical need exists for therapeutic regimens in transplantation that allow immediate postoperative graft function, thereby improving graft survival. Delayed graft function (DGF) after transplantation is the most common complication affecting kidney allographs in the immediate transplant period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure
- What is being tested?
- rhC1INH and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2019to Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients receiving a transplanted kidney should satisfy the following to be considered part of the study:
- Has the ability to understand the requirements of the study, is able to provide written informed consent (including consent for the use and disclosure of research related health information).
- Male or female at least 18 years of age.
- Is to be a recipient of a transplant from a deceased donor (donation after cardio-circulatory determination of death criteria).
- Is able to comply with standard of care induction therapy requirement, such as antibody induction therapy with rabbit polyclonal anti-thymocyte globulin,anti-CD25 (anti-IL2R), or Anti-CD52.
- A female subject is eligible to enter the study if she is:
Show all 12Show fewer
- Not pregnant or nursing
- Of non-childbearing potential (i.e., post-menopausal defined as having been amenorrheic for at least 1 year prior to screening, or has had a bilateral tubal ligation at least 6 months prior to administration of study drug or bilateral oophorectomy or complete hysterectomy).
- If of childbearing potential, must have a negative serum pregnancy test within 48 hours prior to transplant surgery and be using an effective means of contraception (per the site-specific guidelines or using 2 methods of birth control concurrently, whichever is more stringent) which will be continued until the Day 180 visit.
- Male subjects with female partners of childbearing potential must agree to use an effective means of contraception (per the site-specific guidelines or use 2 methods of birth control concurrently, whichever is more stringent), which will be continued until the Day 180 visit. They will also agree not to donate sperm until 6 months after dosing.
- Must be up-to-date on cancer screening according to site-specific guidelines and past medical history must be negative for biopsy-confirmed malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ or carcinoma of the cervix in situ.
- Must be willing to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations.
Who cannot join
- Use of an investigational drug in the 30 days before surgery.
- Participation in any other research study (drug or non-drug) without prior approval from the sponsor investigator.
- Recipient of a live donor kidney or a kidney from a brain death donor (DBD) donor.
- Recipient of donor kidney preserved with normothermic machine perfusion.
- Scheduled to undergo multiorgan transplantation.
- Has a planned transplant of kidneys that are implanted en-bloc (dual kidney transplantation).
Show all 35Show fewer
- Has planned transplant of dual kidneys (from the same donor) transplanted not en-bloc.
- Has lost first kidney transplant due to graft thrombosis.
- Is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy under another IND/CTA for ischemic/reperfusion injury immediately prior to organ recovery.
- Known hypersensitivity to human monoclonal antibodies or any of the study drug excipients.
- Previous hypersensitivity to basiliximab, Campath-1H or antithymocyte globulin (ATG).
- History of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin, or cervical intraepithelial neoplasia.
- HIV positive recipients.
- Hepatitis B surface antigen positive kidney transplant recipients.
- Hepatitis B core antibody positive kidney transplant recipients.
- Hepatitis C virus positive (HCV+) patients who are either untreated or have failed to demonstrate sustained viral remission for more than 12 months after anti-viral treatment.
- Presence of clinically significant infections requiring continued therapy.
- Positive screening for active tuberculosis.
- Existence of any surgical or medical condition, other than the current transplantation which, in the opinion of the investigator, might significantly alter the distribution, metabolism or excretion of study medication.
- Has a positive T- or B-cell cross-match by NIH anti-globulin lymphocytotoxicity method or CDC crossmatch method, if performed.
- Has a positive T- or B-cell flow cross-match (over 250 channel shift) AND donor specific anti-HLA antibody (DSA) detected by flow cytometry (Luminex®) based antigen-specific anti-HLA antibody testing (over 4000 MFI) or by similar methodology, if performed.
- History or presence of a medical condition or disease that in the investigator's assessment would place the patient at an unacceptable risk for study participation.
- Lactating or pregnant woman.
- Patient institutionalized by administrative or court order.
- HLA or ABO incompatible kidney defined as a positive cytotoxic crossmatch or positive flow cross match.
- Patients with known prothrombotic disorder (e.g. homozygous factor V leiden)
- History of thrombosis or hypercoagulable state excluding access clotting
- History of administration of C1INH containing products or recombinant C1INH within 15 days prior to study entry.
- Patient with an abnormal Thromboelastogram.- results must be reported out prior to dosing (Defined by Coagulation Index of >3.0)
- Patients on warfarin or other anti-coagulants or anti-platelets, such as Plavix, low molecular weight heparin (Low-dose aspirin prophylaxis allowed) due to a history or thrombotic or embolic events, or at a significantly increased risk for thrombosis due to conditions such as carotid stenosis or prosthetic valves.
- Patients with known contraindication to treatment with C1INH
- Patients with elevated abnormal platelet function (PLT>500,000).
- Known or suspected allergy to rabbits and rabbit-derived products. History of immediate hypersensitivity reactions, including anaphylaxis, to C1 esterase inhibitor preparations.
- Patients belonging to vulnerable populations: refers to but not limited to children, minors, pregnant women, prisoners, terminally ill patients, comatose, physically and intellectually challenged individuals, institutionalized, visual or hearing impaired, refugees, international research, and educationally disabled healthy volunteers.
- Diagnosis of reversible Acute Kidney Injury
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53792
Luis Fernandez, MD, 608-263-9903, luis@surgery.wisc.edu
Luis Fernandez, MD
About this study
Official title: A Phase I/II,Single Center,Randomized,Double-Blind,Placebo-Controlled Study to Evaluate the Feasibility of Using Human Recombinant C1 Inhibitor(RUCONEST®) as a Therapeutic Strategy to Reduce the Incidence of Delayed Graft Function in Recipients of Kidneys From Donation After Cardio-Circulatory Death
An unmet medical need exists for therapeutic regimens in transplantation that allow immediate postoperative graft function, thereby improving graft survival. Delayed graft function (DGF) after transplantation is the most common complication affecting kidney allographs in the immediate transplant period. The specific aim of this study is to evaluate the effect of recombinant human C1-inhibitor (rhC1INH), as a kidney recipient intra- and post operative treatment strategy to decrease systemic inflammation and decrease the incidence of DGF from donation after cardiac death donors (DCD).
Read the detailed description
This is a randomized, single-center double blinded study.
The main objective of this study are to determine the ability of rhC1INH to reduce the incidence and severity of delayed graft function in comparison to placebo in recipients of kidneys after cardio-circulatory determination of death (DCD).
This trial has specifically been designed to evaluate the protective effect of rhC1INH treatment in patients at high risk of developing DGF. The selection of potential donors to be part of this study will be limited to the population of DCD donors which have historically shown a risk of developing DGF ranging between 40-55%. Participation in each group will be randomly assigned. Treatment will be administered by an intra-operative infusion of placebo or rhC1INH (100 Units/kg) IV followed by twice a day infusion of 50 Units/Kg IV for the following 48 hours.
A total of 20 subjects will be divided into 2 groups:
Group 1: Control group: standard recipient management + placebo (0.9% Sodium Chloride IV to equal volume of investigational arm: intraoperatively, and then every 12 hours x 2 = total of 3 doses). treatment (n=10) Group 2: Standard recipient management + 100 U/kg intraoperative followed by 50 U/kg every 12 hours x 2 = total of 3 doses (200 U/kg).
Max dose 8400 units for the initial dose and 4200 units maximum for the second and third doses.
- Conditions
- Kidney Failure
- Being tested
- rhC1INH, Saline Solution
- Keywords
- Delayed graft function
- Medical subject headings
- Renal Insufficiency, Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhC1INHDrug
Also called ruconest
C1 esterase inhibitor
Saline SolutionOther
saline solution
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Intervention is saline solution placebo (0.9% Sodium Chloride IV to equal volume of investigational arm: intraoperatively, and then every 12 hours x 2 = total of 3 doses) Receives: Other: Saline Solution |
| rhC1INH | Experimental | Intervention is rhC1INH 100 U/kg intraoperative followed by 50 U/kg every 12 hours x 2 = total of 3 doses (200 U/kg) Receives: Drug: rhC1INH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that do not meet DGF criteria based on creatinine levels following kidney transplantation from DCD donor who are treated with study drug compared to placebo
Incidence of delayed graft function in the first 7 days following kidney transplant as defined as the initiation of dialysis in the first 7-days post transplantation and functional DGF as defined as a failure of the serum creatinine to decrease by at least 10% daily on 3 successive days during the first week post transplantation.
Measured: over a 12 month period
Secondary outcomes (8)
Incidence of adverse and serious adverse events will be assessed via descriptive statistics method
The feasibility of different statistical methods to analyze the incidence of adverse and serious adverse events
Measured: over a 12 month period
Ascertain whether any unexpected toxicities will occur in this patient population according to the Common Toxicity Criteria for Adverse Events (CTCAE) patient population
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: over a 12 month period
Willingness of participation will be evaluated based on number of potential study candidates (approaches) compared to the number of candidates that enroll in the study likely response rates
Enrollment rate of eligible participants
Measured: over a 12 month period
Tolerability following drug administration as measured by blood pressure
The ability and tolerability to administer the study drug 3 times with appropriate post administration by recording blood pressure in mmHg
Measured: over a 12 month period
Tolerability following drug administration as measured by HR (heart rate)
The ability and tolerability to administer the study drug 3 times with appropriate pre and post administration by recording heart rate as beats per minute
Measured: over a 12 month period
Tolerability following drug administration as measured by temperature
The ability and tolerability to administer the study drug 3 times with appropriate pre and post administration by recording temperature in degrees Fahrenheit
Measured: over a 12 month period
Tolerability following drug administration as measured by respiratory rate
The ability and tolerability to administer the study drug 3 times with appropriate pre and post administration by recording the respiratory rate as breathes per minute
Measured: over a 12 month period
Tolerability of drug administration as measured by urinary output
To assess tolerability, upon administration of the drug, amount of urinary output will be recorded in mL
Measured: over a 12 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start21 Jun 2019
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (69)Papers the sponsor has linked to this study.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention versus placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Pharming Technologies B.V.
- Responsible party
- Sponsor
- Investigators
- Luis Fernandez, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791476
- Sponsor's protocol ID
- 2017-1325
- Other IDs
- A539742, SMPH/SURGERY/TRANSPLANT, Protocol Version 12/26/2019
- Status last verified
- Jul 2020
- First submitted
- 12 Jul 2018
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ricklin D, Hajishengallis G, Yang K, Lambris JD. Complement: a key system for immune surveillance and homeostasis. Nat Immunol. 2010 Sep;11(9):785-97. doi: 10.1038/ni.1923. Epub 2010 Aug 19.
PubMed 20720586Ricklin D, Lambris JD. Complement in immune and inflammatory disorders: pathophysiological mechanisms. J Immunol. 2013 Apr 15;190(8):3831-8. doi: 10.4049/jimmunol.1203487.
PubMed 23564577Zipfel PF, Skerka C. Complement regulators and inhibitory proteins. Nat Rev Immunol. 2009 Oct;9(10):729-40. doi: 10.1038/nri2620. Epub 2009 Sep 4.
PubMed 19730437Blom AM, Villoutreix BO, Dahlback B. Complement inhibitor C4b-binding protein-friend or foe in the innate immune system? Mol Immunol. 2004 Apr;40(18):1333-46. doi: 10.1016/j.molimm.2003.12.002.
PubMed 15072852Jozsi M, Zipfel PF. Factor H family proteins and human diseases. Trends Immunol. 2008 Aug;29(8):380-7. doi: 10.1016/j.it.2008.04.008. Epub 2008 Jul 2.
PubMed 18602340Davis AE 3rd. Biological effects of C1 inhibitor. Drug News Perspect. 2004 Sep;17(7):439-46. doi: 10.1358/dnp.2004.17.7.863703.
PubMed 15514703Eltzschig HK, Eckle T. Ischemia and reperfusion--from mechanism to translation. Nat Med. 2011 Nov 7;17(11):1391-401. doi: 10.1038/nm.2507.
PubMed 22064429Kono H, Rock KL. How dying cells alert the immune system to danger. Nat Rev Immunol. 2008 Apr;8(4):279-89. doi: 10.1038/nri2215. Epub 2008 Mar 14.
PubMed 18340345Friedewald JJ, Rabb H. Inflammatory cells in ischemic acute renal failure. Kidney Int. 2004 Aug;66(2):486-91. doi: 10.1111/j.1523-1755.2004.761_3.x.
PubMed 15253694Diepenhorst GM, van Gulik TM, Hack CE. Complement-mediated ischemia-reperfusion injury: lessons learned from animal and clinical studies. Ann Surg. 2009 Jun;249(6):889-99. doi: 10.1097/SLA.0b013e3181a38f45.
PubMed 19474697Guo RF, Ward PA. Role of C5a in inflammatory responses. Annu Rev Immunol. 2005;23:821-52. doi: 10.1146/annurev.immunol.23.021704.115835.
PubMed 15771587McCaughan JA, O'Rourke DM, Courtney AE. The complement cascade in kidney disease: from sideline to center stage. Am J Kidney Dis. 2013 Sep;62(3):604-14. doi: 10.1053/j.ajkd.2012.12.033. Epub 2013 Mar 13.
PubMed 23489674Gasque P. Complement: a unique innate immune sensor for danger signals. Mol Immunol. 2004 Nov;41(11):1089-98. doi: 10.1016/j.molimm.2004.06.011.
PubMed 15476920Zhou W, Farrar CA, Abe K, Pratt JR, Marsh JE, Wang Y, Stahl GL, Sacks SH. Predominant role for C5b-9 in renal ischemia/reperfusion injury. J Clin Invest. 2000 May;105(10):1363-71. doi: 10.1172/JCI8621.
PubMed 10811844Weiser MR, Williams JP, Moore FD Jr, Kobzik L, Ma M, Hechtman HB, Carroll MC. Reperfusion injury of ischemic skeletal muscle is mediated by natural antibody and complement. J Exp Med. 1996 May 1;183(5):2343-8. doi: 10.1084/jem.183.5.2343.
PubMed 8642343
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II,Single Center,Randomized,Double-Blind,Placebo-Controlled Study to Evaluate the Feasibility of Using Human Recombinant C1 Inhibitor(RUCONEST®) as a Therapeutic Strategy to Reduce the Incidence of Delayed Graft Function in Recipients of Kidneys From Donation After Cardio-Circulatory Death
- ClinicalTrials.gov ID
- NCT03791476
- Acronym / sponsor ID
- 2017-1325
- Conditions
- Kidney Failure
- Keywords
- Delayed graft function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Pharming Technologies B.V.
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 2 Jan 2019 (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.
An unmet medical need exists for therapeutic regimens in transplantation that allow immediate postoperative graft function, thereby improving graft survival. Delayed graft function (DGF) after transplantation is the most common complication affecting kidney allographs in the immediate transplant period. The specific aim of this study is to evaluate the effect of recombinant human C1-inhibitor (rhC1INH), as a kidney recipient intra- and post operative treatment strategy to decrease systemic inflammation and decrease the incidence of DGF from donation after cardiac death donors (DCD).
Detailed description
This is a randomized, single-center double blinded study.
The main objective of this study are to determine the ability of rhC1INH to reduce the incidence and severity of delayed graft function in comparison to placebo in recipients of kidneys after cardio-circulatory determination of death (DCD).
This trial has specifically been designed to evaluate the protective effect of rhC1INH treatment in patients at high risk of developing DGF. The selection of potential donors to be part of this study will be limited to the population of DCD donors which have historically shown a risk of developing DGF ranging between 40-55%. Participation in each group will be randomly assigned. Treatment will be administered by an intra-operative infusion of placebo or rhC1INH (100 Units/kg) IV followed by twice a day infusion of 50 Units/Kg IV for the following 48 hours.
A total of 20 subjects will be divided into 2 groups:
Group 1: Control group: standard recipient management + placebo (0.9% Sodium Chloride IV to equal volume of investigational arm: intraoperatively, and then every 12 hours x 2 = total of 3 doses). treatment (n=10) Group 2: Standard recipient management + 100 U/kg intraoperative followed by 50 U/kg every 12 hours x 2 = total of 3 doses (200 U/kg).
Max dose 8400 units for the initial dose and 4200 units maximum for the second and third doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Intervention versus placebo
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Saline SolutionIntervention is saline solution placebo (0.9% Sodium Chloride IV to equal volume of investigational arm: intraoperatively, and then every 12 hours x 2 = total of 3 doses) |
| rhC1INH | Experimental | Drug: rhC1INHIntervention is rhC1INH 100 U/kg intraoperative followed by 50 U/kg every 12 hours x 2 = total of 3 doses (200 U/kg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult patients receiving a transplanted kidney should satisfy the following to be considered part of the study:
- Has the ability to understand the requirements of the study, is able to provide written informed consent (including consent for the use and disclosure of research related health information).
- Male or female at least 18 years of age.
- Is to be a recipient of a transplant from a deceased donor (donation after cardio-circulatory determination of death criteria).
- Is able to comply with standard of care induction therapy requirement, such as antibody induction therapy with rabbit polyclonal anti-thymocyte globulin,anti-CD25 (anti-IL2R), or Anti-CD52.
Key exclusion criteria (35 listed)
- Use of an investigational drug in the 30 days before surgery.
- Participation in any other research study (drug or non-drug) without prior approval from the sponsor investigator.
- Recipient of a live donor kidney or a kidney from a brain death donor (DBD) donor.
- Recipient of donor kidney preserved with normothermic machine perfusion.
- Scheduled to undergo multiorgan transplantation.
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 |
|---|---|---|
| rhC1INHAlso: ruconestC1 esterase inhibitor | Drug | rhC1INH |
| Saline Solutionsaline solution | Other | Control Group |
Primary outcome
Number of patients that do not meet DGF criteria based on creatinine levels following kidney transplantation from DCD donor who are treated with study drug compared to placebo
Time frame: over a 12 month period
Incidence of delayed graft function in the first 7 days following kidney transplant as defined as the initiation of dialysis in the first 7-days post transplantation and functional DGF as defined as a failure of the serum creatinine to decrease by at least 10% daily on 3 successive days during the first week post transplantation.
8 secondary outcomes
Incidence of adverse and serious adverse events will be assessed via descriptive statistics method
Time frame: over a 12 month period
Ascertain whether any unexpected toxicities will occur in this patient population according to the Common Toxicity Criteria for Adverse Events (CTCAE) patient population
Time frame: over a 12 month period
Willingness of participation will be evaluated based on number of potential study candidates (approaches) compared to the number of candidates that enroll in the study likely response rates
Time frame: over a 12 month period
Tolerability following drug administration as measured by blood pressure
Time frame: over a 12 month period
Tolerability following drug administration as measured by HR (heart rate)
Time frame: over a 12 month period
Tolerability following drug administration as measured by temperature
Time frame: over a 12 month period
Tolerability following drug administration as measured by respiratory rate
Time frame: over a 12 month period
Tolerability of drug administration as measured by urinary output
Time frame: over a 12 month period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Background: PubMed 20720586Ricklin D, Hajishengallis G, Yang K, Lambris JD. Complement: a key system for immune surveillance and homeostasis. Nat Immunol. 2010 Sep;11(9):785-97. doi: 10.1038/ni.1923. Epub 2010 Aug 19.
- Background: PubMed 23564577Ricklin D, Lambris JD. Complement in immune and inflammatory disorders: pathophysiological mechanisms. J Immunol. 2013 Apr 15;190(8):3831-8. doi: 10.4049/jimmunol.1203487.
- Background: PubMed 19730437Zipfel PF, Skerka C. Complement regulators and inhibitory proteins. Nat Rev Immunol. 2009 Oct;9(10):729-40. doi: 10.1038/nri2620. Epub 2009 Sep 4.
- Background: PubMed 15072852Blom AM, Villoutreix BO, Dahlback B. Complement inhibitor C4b-binding protein-friend or foe in the innate immune system? Mol Immunol. 2004 Apr;40(18):1333-46. doi: 10.1016/j.molimm.2003.12.002.
- Background: PubMed 18602340Jozsi M, Zipfel PF. Factor H family proteins and human diseases. Trends Immunol. 2008 Aug;29(8):380-7. doi: 10.1016/j.it.2008.04.008. Epub 2008 Jul 2.
- Background: PubMed 15514703Davis AE 3rd. Biological effects of C1 inhibitor. Drug News Perspect. 2004 Sep;17(7):439-46. doi: 10.1358/dnp.2004.17.7.863703.
- Background: PubMed 22064429Eltzschig HK, Eckle T. Ischemia and reperfusion--from mechanism to translation. Nat Med. 2011 Nov 7;17(11):1391-401. doi: 10.1038/nm.2507.
- Background: PubMed 18340345Kono H, Rock KL. How dying cells alert the immune system to danger. Nat Rev Immunol. 2008 Apr;8(4):279-89. doi: 10.1038/nri2215. Epub 2008 Mar 14.
- Background: PubMed 15253694Friedewald JJ, Rabb H. Inflammatory cells in ischemic acute renal failure. Kidney Int. 2004 Aug;66(2):486-91. doi: 10.1111/j.1523-1755.2004.761_3.x.
- Background: PubMed 19474697Diepenhorst GM, van Gulik TM, Hack CE. Complement-mediated ischemia-reperfusion injury: lessons learned from animal and clinical studies. Ann Surg. 2009 Jun;249(6):889-99. doi: 10.1097/SLA.0b013e3181a38f45.
- Background: PubMed 15771587Guo RF, Ward PA. Role of C5a in inflammatory responses. Annu Rev Immunol. 2005;23:821-52. doi: 10.1146/annurev.immunol.23.021704.115835.
- Background: PubMed 23489674McCaughan JA, O'Rourke DM, Courtney AE. The complement cascade in kidney disease: from sideline to center stage. Am J Kidney Dis. 2013 Sep;62(3):604-14. doi: 10.1053/j.ajkd.2012.12.033. Epub 2013 Mar 13.
- Individual participant dataSharing planned: No
Related trials for Kidney Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Luis Fernandez principal investigator
University of Wisconsin, Madison
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 rhC1INH and Saline Solution in people with Kidney Failure, run by University of Wisconsin, Madison at 1 site in United States.
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 12 inclusion and 35 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: status not confirmed, as of the sponsor's last update on 14 Dec 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Fernandez, MD (608-263-9903, luis@surgery.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that do not meet DGF criteria based on creatinine levels following kidney transplantation from DCD donor who are treated with study drug compared to placebo (time frame: over a 12 month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03791476, which also lists 69 linked publications.
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 14 Dec 2020.