ImmunosuppressionMAIDENNCT04989686
Microsampling Assays for Immunosuppressive Drugs in Children
An observational study of Immunosuppression, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Immunosuppressive therapy is used to treat and manage solid organ and bone marrow/stem cell transplants in children. However, it can be harmful if too little or too much is given. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Immunosuppression
- What is being tested?
- Microsampling
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2023to 1 May 2025
- Phase
- Observational
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children receiving immunosuppressive therapy and scheduled/anticipated blood draw to quantify the concentration of the immunosuppressive drugs (CYA, TAC, and SIR) for clinical indications.
Who may be able to join
- Males and females <18 years of age
- Weight greater than 5 kg
- Receiving CYA, TAC, and/or SIR as standard of care
- Has scheduled/anticipated blood draw to quantify the concentration of CYA, TAC, and SIR* for clinical indications
- Parental/guardian permission (informed consent), and subject's assent if applicable.
Who cannot join
- 1) Unable to provide blood samples.
- Potential subjects and their parents/guardians may be approached prior to having a blood draw scheduled if they meet all other eligibility criteria.
- Sub-Study Criteria:
- Sub-study criteria for child participants will not differ from the main study. Adult participants are required to be a parent/legal guardian of a study subject.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Phildelphia
Philadelphia, Pennsylvania, 19104
About this study
Immunosuppressive therapy is used to treat and manage solid organ and bone marrow/stem cell transplants in children. However, it can be harmful if too little or too much is given. Monitoring immunosuppressive drug (cyclosporine A, tacrolimus, and sirolimus) concentrations in the blood is important to ensure that the drug is given safely and effectively, but current approaches for collecting blood from a vein are painful and often difficult in children. Investigators seek to compare a new approach for monitoring immunosuppressive drug concentrations using a novel small volume blood sampling device, called Tasso-M20, to the traditional way of collecting blood from a vein. Additionally Investigators are interested in assessing patient and family perceptions of the Tasso-M20 device being used for immunosuppressive therapy and their comfortability using the device outside of a clinical setting.
The primary objective of this project is to identify the relationship between cyclosporine A (CYA), tacrolimus (TAC), and sirolimus (SIR) concentrations in the venous blood (gold-standard) and capillary whole blood obtained using the microsampling device Tasso-M20.
Read more
The secondary objective of this study is to investigate the stability of CYA, TAC, and SIR in blood samples collected using the Tasso-M20 device under the conditions of shipping and storage.
The sub-study objective is to thematically compare subjects' and families' perceptions of blood collection via the Tasso-M20 device and standard venous blood collection.
Read the detailed description
Immunosuppressive therapy is used to treat and manage solid organ and bone marrow/stem cell transplants; however, suboptimal dosing can lead to organ rejection and graft failure. Immunosuppressant drugs require therapeutic drug monitoring (TDM) to ensure dosing is adequate and therapeutic concentrations are achieved and maintained. The optimal blood concentrations of these drugs are critical to minimize toxicity and simultaneously prevent allograft rejection in an individual transplant patient. Often life-long TDM is required necessitating hospital or laboratory visits for routine venous blood sampling by phlebotomy. Immunosuppressive drugs, cyclosporine A (CYA), tacrolimus (TAC), and sirolimus (SIR) require routine TDM. This entails immunocompromised people leaving their homes for laboratory visits, potentially increasing their risk of acquiring infections.
TDM for CYA, TAC, and SIR are required due to their narrow therapeutic targets: CYA 150-400 ng/mL, TAC 5-12 ng/mL, and SIR 4-12 ng/mL. CYA, TAC, and SIR are primarily distributed in erythrocytes and should be quantified in whole blood. Immunoassays and the liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays are the two commonly used methods of TDM for CYA, TAC, and SIR. While immunoassays provide an accurate measurement of concentrations, they often have some limitations on specificity. LC-MS/MS assays are very specific and efficient since they can quantify multiple analytes with a single method. At the Children's Hospital of Philadelphia (CHOP), the clinical TDM immunoassays for CYA, TAC, and SIR require 0.5-1.0 mL of blood. TDM immunoassays require blood collection by a trained practitioner.
Volumetric absorptive microsampling (VAMS) with an FDA-approved Tasso-M20 device allows for the accurate and precise collection of a fixed volume of blood from a capillary needle without the need for phlebotomy. The Tasso-M20 (FDA Class 1 exempt device) consists of a sample head with a lancet that is activated with the push of a button to accurately and painlessly collect blood samples from the deltoid (or similar) muscle (capillary sampling) of the subjects on all four tips (17.5 µL each). An LC-MS/MS assay with 20 µL blood, as obtained by the Tasso device, was shown to provide the required test range for TDM of trough values. This microsampling technique could be utilized clinically to promote the provision of TDM in children but has not been studied for immunosuppressive drugs (CYA, TAC, and SIR) in children.
Children and their parents/guardians who consent to the optional sub-study will be administered a brief survey after one study visit, to ask about their perceptions of the two methods of blood collection that they experienced at the visit.
- Conditions
- Immunosuppression
- Being tested
- Microsampling
- Keywords
- microsampling, cyclosporine A, tacrolimus, sirolimus, Tasso-M20
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrosamplingOther
Volumetric absorptive microsampling (VAMS) with Tasso-M20 devices allows for the accurate and precise collection of a fixed small volume of blood from a capillary needle without the need for phlebotomy.
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine A | 1. Males and females <18 years of age
2. Weight greater than 5 kg
3. Receiving cyclosporine A as the standard of care
4. Has scheduled/anticipated blood draw to quantify the concentration of cyclosporine A for clinical indications
5. Parental/guardian permission (informed consent), and subject's assent if applicable. Receives: Other: Microsampling | |
| Tacrolimus | 1. Males and females <18 years of age
2. Weight greater than 5 kg
3. Receiving tacrolimus as the standard of care
4. Has scheduled/anticipated blood draw to quantify the concentration of tacrolimus for clinical indications
5. Parental/guardian permission (informed consent), and subject's assent if applicable. Receives: Other: Microsampling | |
| Sirolimus | 1. Males and females <18 years of age
2. Weight greater than 5 kg
3. Receiving sirolimus as the standard of care
4. Has scheduled/anticipated blood draw to quantify the concentration of sirolimus for clinical indications
5. Parental/guardian permission (informed consent), and subject's assent if applicable. Receives: Other: Microsampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical validation of microsampling assay of Tacrolimus
Capillary whole blood specimens will be obtained via the Tasso M-20 sampling device to determine validity of the assay compared to venous blood samples (gold standard and used clinically) in measuring Tacrolimus concentration levels.
Measured: up to 20 months
Clinical validation of microsampling assay of Sirolimus
Capillary whole blood specimens will be obtained via the Tasso M-20 sampling device to determine validity of the assay compared to venous blood samples (gold standard and used clinically) in measuring Sirolimus concentration levels.
Measured: up to 20 months
Clinical validation of microsampling assay of Cyclosporine A
Capillary whole blood specimens will be obtained via the Tasso M-20 sampling device to determine validity of the assay compared to venous blood samples (gold standard and used clinically) in measuring Cyclosporin A concentration levels.
Measured: up to 20 months
Secondary outcomes (6)
Stability of blood samples which contains immunosuppressive drug Tacrolimus under conditions of shipping
Blood specimens obtained by the Tasso M20 device will be used to investigate the stability of blood samples obtained from the Tasso M-20 device containing immunosuppressive drugs Tacrolimus under the conditions of shipping
Measured: up to 20 months
Stability of blood samples obtained which contains immunosuppressive drug Sirolimus under conditions of shipping
Blood specimens obtained by the Tasso M20 device will be used to investigate the stability of blood samples obtained from the Tasso M-20 device containing immunosuppressive drugs sirolimus under the conditions of shipping
Measured: up to 20 months
Stability of blood samples containing immunosuppressive drug Cyclosporine A under conditions of shipping
Blood specimens obtained by the Tasso M20 device will be used to investigate the stability of blood samples obtained by the Tasso M-20 device which contains immunosuppressive drugs cyclosporine A under the conditions of shipping
Measured: up to 20 months
Stability of blood samples which contains immunosuppressive drug Tacrolimus under conditions of storage
Blood specimens obtained by the Tasso M20 device will be used to investigate the stability of blood samples containing immunosuppressive drugs Tacrolimus under the conditions of storage
Measured: up to 20 months
Stability of blood samples which contains immunosuppressive drug Sirolimus under conditions of storage
Blood specimens obtained from the Tasso device will be used to investigate the stability of blood samples containing immunosuppressive drugs Sirolimus under the conditions of storage
Measured: up to 20 months
Stability of blood samples obtained which contains immunosuppressive drug Cyclosporine A under conditions of storage
Blood specimens obtained from the Tasso M20 device will be used to investigate the stability of blood samples containing immunosuppressive drugs Cyclosporin A under the conditions of storage
Measured: up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start8 Jun 2023
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989686
- Sponsor's protocol ID
- 22-020410
- Other IDs
- 5R21HD106103-02
- Acronym
- MAIDEN
- Status last verified
- Jul 2025
- First submitted
- 26 Jul 2021
- Last updated
- 14 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Enderby C, Keller CA. An overview of immunosuppression in solid organ transplantation. Am J Manag Care. 2015 Jan;21(1 Suppl):s12-23.
PubMed 25734416Penack O, Marchetti M, Ruutu T, Aljurf M, Bacigalupo A, Bonifazi F, Ciceri F, Cornelissen J, Malladi R, Duarte RF, Giebel S, Greinix H, Holler E, Lawitschka A, Mielke S, Mohty M, Arat M, Nagler A, Passweg J, Schoemans H, Socie G, Solano C, Vrhovac R, Zeiser R, Kroger N, Basak GW. Prophylaxis and management of graft versus host disease after stem-cell transplantation for haematological malignancies: updated consensus recommendations of the European Society for Blood and Marrow Transplantation. Lancet Haematol. 2020 Feb;7(2):e157-e167. doi: 10.1016/S2352-3026(19)30256-X.
PubMed 32004485Baert F, Vermeire S, Noman M, Van Assche G, D'Haens G, Rutgeerts P. Management of ulcerative colitis and Crohn's disease. Acta Clin Belg. 2004 Sep-Oct;59(5):304-14. doi: 10.1179/acb.2004.045.
PubMed 15641402Cheng-Lai A, Frishman WH. Sirolimus-eluting coronary stents: novel devices for the management of coronary artery disease. Am J Ther. 2004 May-Jun;11(3):218-28. doi: 10.1097/00045391-200405000-00011.
PubMed 15133538Zhang Y, Zhang R. Recent advances in analytical methods for the therapeutic drug monitoring of immunosuppressive drugs. Drug Test Anal. 2018 Jan;10(1):81-94. doi: 10.1002/dta.2290. Epub 2017 Sep 28.
PubMed 28851030Wallemacq P, Goffinet JS, O'Morchoe S, Rosiere T, Maine GT, Labalette M, Aimo G, Dickson D, Schmidt E, Schwinzer R, Schmid RW. Multi-site analytical evaluation of the Abbott ARCHITECT tacrolimus assay. Ther Drug Monit. 2009 Apr;31(2):198-204. doi: 10.1097/FTD.0b013e31819c6a37.
PubMed 19258928Veenhof H, Koster RA, Junier LAT, Berger SP, Bakker SJL, Touw DJ. Volumetric absorptive microsampling and dried blood spot microsampling vs. conventional venous sampling for tacrolimus trough concentration monitoring. Clin Chem Lab Med. 2020 Sep 25;58(10):1687-1695. doi: 10.1515/cclm-2019-1260.
PubMed 32412437Klak A, Pauwels S, Vermeersch P. Preanalytical considerations in therapeutic drug monitoring of immunosuppressants with dried blood spots. Diagnosis (Berl). 2019 Mar 26;6(1):57-68. doi: 10.1515/dx-2018-0034.
PubMed 30808156Denniff P, Spooner N. Volumetric absorptive microsampling: a dried sample collection technique for quantitative bioanalysis. Anal Chem. 2014 Aug 19;86(16):8489-95. doi: 10.1021/ac5022562. Epub 2014 Aug 6.
PubMed 25058158Roadcap B, Hussain A, Dreyer D, Carter K, Dube N, Xu Y, Anderson M, Berthier E, Vazvaei F, Bateman K, Woolf E. Clinical application of volumetric absorptive microsampling to the gefapixant development program. Bioanalysis. 2020 Jul;12(13):893-904. doi: 10.4155/bio-2020-0074. Epub 2020 Jul 10.
PubMed 32648772Fedoruk MN. Virtual drug testing: redefining sample collection in a global pandemic. Bioanalysis. 2020 Jun;12(11):715-718. doi: 10.4155/bio-2020-0119. Epub 2020 Jun 12. No abstract available.
PubMed 32530291Capiau S, Veenhof H, Koster RA, Bergqvist Y, Boettcher M, Halmingh O, Keevil BG, Koch BCP, Linden R, Pistos C, Stolk LM, Touw DJ, Stove CP, Alffenaar JC. Official International Association for Therapeutic Drug Monitoring and Clinical Toxicology Guideline: Development and Validation of Dried Blood Spot-Based Methods for Therapeutic Drug Monitoring. Ther Drug Monit. 2019 Aug;41(4):409-430. doi: 10.1097/FTD.0000000000000643.
PubMed 31268966Gaies E, Ben Sassi M, Charfi R, Salouage I, Jebabli N, ElJebari H, Klouz A, Daghfous R, Trabelsi S. Therapeutic durg monitoring of cyclosporin using area under the curve in nephrotic syndrome. Tunis Med. 2019 Feb;97(2):360-364.
PubMed 31539095Morales JM, Andres A, Rengel M, Rodicio JL. Influence of cyclosporin, tacrolimus and rapamycin on renal function and arterial hypertension after renal transplantation. Nephrol Dial Transplant. 2001;16 Suppl 1:121-4. doi: 10.1093/ndt/16.suppl_1.121.
PubMed 11369839Zhang X, Lin G, Tan L, Li J. Current progress of tacrolimus dosing in solid organ transplant recipients: Pharmacogenetic considerations. Biomed Pharmacother. 2018 Jun;102:107-114. doi: 10.1016/j.biopha.2018.03.054. Epub 2018 Mar 22.
PubMed 29550633
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microsampling Assays for Immunosuppressive Drugs in Children
- ClinicalTrials.gov ID
- NCT04989686
- Acronym / sponsor ID
- MAIDEN / 22-020410
- Conditions
- Immunosuppression
- Keywords
- microsampling, cyclosporine A, tacrolimus, sirolimus, Tasso-M20
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 4 Aug 2021 (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.
Immunosuppressive therapy is used to treat and manage solid organ and bone marrow/stem cell transplants in children. However, it can be harmful if too little or too much is given. Monitoring immunosuppressive drug (cyclosporine A, tacrolimus, and sirolimus) concentrations in the blood is important to ensure that the drug is given safely and effectively, but current approaches for collecting blood from a vein are painful and often difficult in children. Investigators seek to compare a new approach for monitoring immunosuppressive drug concentrations using a novel small volume blood sampling device, called Tasso-M20, to the traditional way of collecting blood from a vein. Additionally Investigators are interested in assessing patient and family perceptions of the Tasso-M20 device being used for immunosuppressive therapy and their comfortability using the device outside of a clinical setting.
The primary objective of this project is to identify the relationship between cyclosporine A (CYA), tacrolimus (TAC), and sirolimus (SIR) concentrations in the venous blood (gold-standard) and capillary whole blood obtained using the microsampling device Tasso-M20.
The secondary objective of this study is to investigate the stability of CYA, TAC, and SIR in blood samples collected using the Tasso-M20 device under the conditions of shipping and storage.
The sub-study objective is to thematically compare subjects' and families' perceptions of blood collection via the Tasso-M20 device and standard venous blood collection.
Detailed description
Immunosuppressive therapy is used to treat and manage solid organ and bone marrow/stem cell transplants; however, suboptimal dosing can lead to organ rejection and graft failure. Immunosuppressant drugs require therapeutic drug monitoring (TDM) to ensure dosing is adequate and therapeutic concentrations are achieved and maintained. The optimal blood concentrations of these drugs are critical to minimize toxicity and simultaneously prevent allograft rejection in an individual transplant patient. Often life-long TDM is required necessitating hospital or laboratory visits for routine venous blood sampling by phlebotomy. Immunosuppressive drugs, cyclosporine A (CYA), tacrolimus (TAC), and sirolimus (SIR) require routine TDM. This entails immunocompromised people leaving their homes for laboratory visits, potentially increasing their risk of acquiring infections.
TDM for CYA, TAC, and SIR are required due to their narrow therapeutic targets: CYA 150-400 ng/mL, TAC 5-12 ng/mL, and SIR 4-12 ng/mL. CYA, TAC, and SIR are primarily distributed in erythrocytes and should be quantified in whole blood. Immunoassays and the liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays are the two commonly used methods of TDM for CYA, TAC, and SIR. While immunoassays provide an accurate measurement of concentrations, they often have some limitations on specificity. LC-MS/MS assays are very specific and efficient since they can quantify multiple analytes with a single method. At the Children's Hospital of Philadelphia (CHOP), the clinical TDM immunoassays for CYA, TAC, and SIR require 0.5-1.0 mL of blood. TDM immunoassays require blood collection by a trained practitioner.
Volumetric absorptive microsampling (VAMS) with an FDA-approved Tasso-M20 device allows for the accurate and precise collection of a fixed volume of blood from a capillary needle without the need for phlebotomy. The Tasso-M20 (FDA Class 1 exempt device) consists of a sample head with a lancet that is activated with the push of a button to accurately and painlessly collect blood samples from the deltoid (or similar) muscle (capillary sampling) of the subjects on all four tips (17.5 µL each). An LC-MS/MS assay with 20 µL blood, as obtained by the Tasso device, was shown to provide the required test range for TDM of trough values. This microsampling technique could be utilized clinically to promote the provision of TDM in children but has not been studied for immunosuppressive drugs (CYA, TAC, and SIR) in children.
Children and their parents/guardians who consent to the optional sub-study will be administered a brief survey after one study visit, to ask about their perceptions of the two methods of blood collection that they experienced at the visit.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine A | – | Other: Microsampling1. Males and females <18 years of age 2. Weight greater than 5 kg 3. Receiving cyclosporine A as the standard of care 4. Has scheduled/anticipated blood draw to quantify the concentration of cyclosporine A for clinical indications 5. Parental/guardian permission (informed consent), and subject's assent if applicable. |
| Tacrolimus | – | Other: Microsampling1. Males and females <18 years of age 2. Weight greater than 5 kg 3. Receiving tacrolimus as the standard of care 4. Has scheduled/anticipated blood draw to quantify the concentration of tacrolimus for clinical indications 5. Parental/guardian permission (informed consent), and subject's assent if applicable. |
| Sirolimus | – | Other: Microsampling1. Males and females <18 years of age 2. Weight greater than 5 kg 3. Receiving sirolimus as the standard of care 4. Has scheduled/anticipated blood draw to quantify the concentration of sirolimus for clinical indications 5. Parental/guardian permission (informed consent), and subject's assent if applicable. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children receiving immunosuppressive therapy and scheduled/anticipated blood draw to quantify the concentration of the immunosuppressive drugs (CYA, TAC, and SIR) for clinical indications.
Key inclusion criteria (5 listed)
- Males and females <18 years of age
- Weight greater than 5 kg
- Receiving CYA, TAC, and/or SIR as standard of care
- Has scheduled/anticipated blood draw to quantify the concentration of CYA, TAC, and SIR* for clinical indications
- Parental/guardian permission (informed consent), and subject's assent if applicable.
Key exclusion criteria (4 listed)
- 1) Unable to provide blood samples.
- Potential subjects and their parents/guardians may be approached prior to having a blood draw scheduled if they meet all other eligibility criteria.
- Sub-study criteria for child participants will not differ from the main study. Adult participants are required to be a parent/legal guardian of a study subject.
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 |
|---|---|---|
| MicrosamplingVolumetric absorptive microsampling (VAMS) with Tasso-M20 devices allows for the accurate and precise collection of a fixed small volume of blood from a capillary needle without the need for phlebotomy. | Other | Cyclosporine A, Sirolimus, Tacrolimus |
Primary outcome
Clinical validation of microsampling assay of Tacrolimus
Time frame: up to 20 months
Capillary whole blood specimens will be obtained via the Tasso M-20 sampling device to determine validity of the assay compared to venous blood samples (gold standard and used clinically) in measuring Tacrolimus concentration levels.
Clinical validation of microsampling assay of Sirolimus
Time frame: up to 20 months
Capillary whole blood specimens will be obtained via the Tasso M-20 sampling device to determine validity of the assay compared to venous blood samples (gold standard and used clinically) in measuring Sirolimus concentration levels.
Clinical validation of microsampling assay of Cyclosporine A
Time frame: up to 20 months
Capillary whole blood specimens will be obtained via the Tasso M-20 sampling device to determine validity of the assay compared to venous blood samples (gold standard and used clinically) in measuring Cyclosporin A concentration levels.
6 secondary outcomes
Stability of blood samples which contains immunosuppressive drug Tacrolimus under conditions of shipping
Time frame: up to 20 months
Stability of blood samples obtained which contains immunosuppressive drug Sirolimus under conditions of shipping
Time frame: up to 20 months
Stability of blood samples containing immunosuppressive drug Cyclosporine A under conditions of shipping
Time frame: up to 20 months
Stability of blood samples which contains immunosuppressive drug Tacrolimus under conditions of storage
Time frame: up to 20 months
Stability of blood samples which contains immunosuppressive drug Sirolimus under conditions of storage
Time frame: up to 20 months
Stability of blood samples obtained which contains immunosuppressive drug Cyclosporine A under conditions of storage
Time frame: up to 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 25734416Enderby C, Keller CA. An overview of immunosuppression in solid organ transplantation. Am J Manag Care. 2015 Jan;21(1 Suppl):s12-23.
- Background: PubMed 32004485Penack O, Marchetti M, Ruutu T, Aljurf M, Bacigalupo A, Bonifazi F, Ciceri F, Cornelissen J, Malladi R, Duarte RF, Giebel S, Greinix H, Holler E, Lawitschka A, Mielke S, Mohty M, Arat M, Nagler A, Passweg J, Schoemans H, Socie G, Solano C, Vrhovac R, Zeiser R, Kroger N, Basak GW. Prophylaxis and management of graft versus host disease after stem-cell transplantation for haematological malignancies: updated consensus recommendations of the European Society for Blood and Marrow Transplantation. Lancet Haematol. 2020 Feb;7(2):e157-e167. doi: 10.1016/S2352-3026(19)30256-X.
- Background: PubMed 15641402Baert F, Vermeire S, Noman M, Van Assche G, D'Haens G, Rutgeerts P. Management of ulcerative colitis and Crohn's disease. Acta Clin Belg. 2004 Sep-Oct;59(5):304-14. doi: 10.1179/acb.2004.045.
- Background: PubMed 15133538Cheng-Lai A, Frishman WH. Sirolimus-eluting coronary stents: novel devices for the management of coronary artery disease. Am J Ther. 2004 May-Jun;11(3):218-28. doi: 10.1097/00045391-200405000-00011.
- Background: PubMed 28851030Zhang Y, Zhang R. Recent advances in analytical methods for the therapeutic drug monitoring of immunosuppressive drugs. Drug Test Anal. 2018 Jan;10(1):81-94. doi: 10.1002/dta.2290. Epub 2017 Sep 28.
- Background: PubMed 19258928Wallemacq P, Goffinet JS, O'Morchoe S, Rosiere T, Maine GT, Labalette M, Aimo G, Dickson D, Schmidt E, Schwinzer R, Schmid RW. Multi-site analytical evaluation of the Abbott ARCHITECT tacrolimus assay. Ther Drug Monit. 2009 Apr;31(2):198-204. doi: 10.1097/FTD.0b013e31819c6a37.
- Background: PubMed 32412437Veenhof H, Koster RA, Junier LAT, Berger SP, Bakker SJL, Touw DJ. Volumetric absorptive microsampling and dried blood spot microsampling vs. conventional venous sampling for tacrolimus trough concentration monitoring. Clin Chem Lab Med. 2020 Sep 25;58(10):1687-1695. doi: 10.1515/cclm-2019-1260.
- Background: PubMed 30808156Klak A, Pauwels S, Vermeersch P. Preanalytical considerations in therapeutic drug monitoring of immunosuppressants with dried blood spots. Diagnosis (Berl). 2019 Mar 26;6(1):57-68. doi: 10.1515/dx-2018-0034.
- Background: PubMed 25058158Denniff P, Spooner N. Volumetric absorptive microsampling: a dried sample collection technique for quantitative bioanalysis. Anal Chem. 2014 Aug 19;86(16):8489-95. doi: 10.1021/ac5022562. Epub 2014 Aug 6.
- Background: PubMed 32648772Roadcap B, Hussain A, Dreyer D, Carter K, Dube N, Xu Y, Anderson M, Berthier E, Vazvaei F, Bateman K, Woolf E. Clinical application of volumetric absorptive microsampling to the gefapixant development program. Bioanalysis. 2020 Jul;12(13):893-904. doi: 10.4155/bio-2020-0074. Epub 2020 Jul 10.
- Background: PubMed 32530291Fedoruk MN. Virtual drug testing: redefining sample collection in a global pandemic. Bioanalysis. 2020 Jun;12(11):715-718. doi: 10.4155/bio-2020-0119. Epub 2020 Jun 12. No abstract available.
- Background: PubMed 31268966Capiau S, Veenhof H, Koster RA, Bergqvist Y, Boettcher M, Halmingh O, Keevil BG, Koch BCP, Linden R, Pistos C, Stolk LM, Touw DJ, Stove CP, Alffenaar JC. Official International Association for Therapeutic Drug Monitoring and Clinical Toxicology Guideline: Development and Validation of Dried Blood Spot-Based Methods for Therapeutic Drug Monitoring. Ther Drug Monit. 2019 Aug;41(4):409-430. doi: 10.1097/FTD.0000000000000643.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunosuppression, run by Children's Hospital of Philadelphia 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 14 Jul 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical validation of microsampling assay of Tacrolimus (time frame: up to 20 months). The study lists 3 primary outcomes in all. 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 NCT04989686, which also lists 24 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 Jul 2025.