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Article ; Online: First-in-human study of JNJ-67571244, a CD33 × CD3 bispecific antibody, in relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

2024 Volume 17, Issue 3, Page(s) e13742

Abstract: Relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) outcomes remain poor. A targeted cluster of differentiation (CD)33 × CD3 bispecific antibody, JNJ-67571244, was assessed to identify the maximum tolerated dose (MTD) ...

Abstract	Relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) outcomes remain poor. A targeted cluster of differentiation (CD)33 × CD3 bispecific antibody, JNJ-67571244, was assessed to identify the maximum tolerated dose (MTD), recommended phase II dose (RP2D), safety and tolerability, and preliminary clinical activity in patients with r/rAML or r/rMDS. This first-in-human, open-label, phase I, dose-escalation/dose-expansion study included patients with r/rAML or r/rMDS who were ineligible for or had exhausted standard therapeutic options. JNJ-67571244 was administered intravenously or subcutaneously using step-up dosing until ≥1 discontinuation condition was met. Outcomes included safety/tolerability, preliminary clinical activity, and systemic pharmacokinetics and pharmacodynamics. The study was terminated after evaluating 10 dose-escalation cohorts (n = 68) and before starting dose-expansion. Overall, 11 (16.2%) patients experienced ≥1 dose-limiting toxicity; all experienced ≥1 treatment-emergent adverse event (TEAE; treatment related: 60 [88.2%]); and 64 (94.1%) experienced ≥1 TEAE of Grade ≥3 toxicity (treatment related: 28 [41.2%]). Although some patients had temporary disease burden reductions, no responses were seen. JNJ-67571244 administration increased multiple cytokines, which coincided with incidence of cytokine release syndrome, infusion-related reactions, and elevated liver function tests. A prolonged step-up strategy was tested to improve tolerability, though this approach did not prevent hepatotoxicity. T-cell activation following treatment suggested target engagement but did not correlate with clinical activity. Safely reaching the projected exposure level for JNJ-67571244 efficacy was not achieved, thus MTD and RP2D were not determined.
MeSH term(s)	Humans ; Antineoplastic Agents/therapeutic use ; Leukemia, Myeloid, Acute/drug therapy ; Myelodysplastic Syndromes/drug therapy ; Sialic Acid Binding Ig-like Lectin 3/immunology
Chemical Substances	Antineoplastic Agents ; CD33 protein, human ; Sialic Acid Binding Ig-like Lectin 3
Language	English
Publishing date	2024-03-01
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.13742
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Article ; Online: First-in-human study of JNJ-63709178, a CD123/CD3 targeting antibody, in relapsed/refractory acute myeloid leukemia.

Boyiadzis, Michael / Desai, Pinkal / Daskalakis, Nikki / Donnellan, William / Ferrante, Lucille / Goldberg, Jenna D / Grunwald, Michael R / Guttke, Christina / Li, Xiang / Perez-Simon, Jose Antonio / Salamero, Olga / Tucker, Trevor / Xu, Xiaoying / Yang, Jay / Pemmaraju, Naveen / Alonso-Dominguez, Juan Manuel

Clinical and translational science

2023 Volume 16, Issue 3, Page(s) 429–435

Abstract: This study aimed to identify a recommended phase II dose and evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary clinical activity of JNJ-63709178, a CD123/CD3 dual-targeting antibody, in patients with relapsed or ... ...

Abstract	This study aimed to identify a recommended phase II dose and evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary clinical activity of JNJ-63709178, a CD123/CD3 dual-targeting antibody, in patients with relapsed or refractory acute myeloid leukemia. Intravenous (i.v.) and subcutaneous (s.c.) administration of JNJ-63709178 were evaluated. The i.v. infusions were administered once every 2 weeks (cohorts 1-5 [n = 17]) or twice weekly (cohorts 6-11 [n = 36]). A twice-weekly s.c. dosing regimen with step-up dosing was also studied (s.c. cohorts 1-2 [n = 9]). Treatment-emergent adverse events (TEAEs) greater than or equal to grade 3 were observed in 11 (65%) patients in cohorts 1-5 and 33 (92%) patients in cohorts 6-11. At the highest i.v. dose (4.8 μg/kg), 5 (71%) patients discontinued treatment due to TEAEs. For s.c. administration (n = 9), eight (89%) patients experienced TEAEs greater than or equal to grade 3 and injection site reactions (≤ grade 3) emerged in all patients. At 4.8 μg/kg (i.v. and s.c.), the mean maximum serum concentrations were 30.3 and 3.59 ng/ml, respectively. Increases in multiple cytokines were observed following i.v. and s.c. administrations, and step-up dosing strategies did not mitigate cytokine production or improve the safety profile and led to limited duration of treatment. Minimal clinical activity was observed across all cohorts. The i.v. and s.c. dosing of JNJ-63709178 was associated with suboptimal drug exposure, unfavorable safety profiles, limited clinical activity, and inability to identify a recommended phase II dose.
MeSH term(s)	Humans ; Interleukin-3 Receptor alpha Subunit/therapeutic use ; Antineoplastic Agents/therapeutic use ; Leukemia, Myeloid, Acute/drug therapy
Chemical Substances	Interleukin-3 Receptor alpha Subunit ; Antineoplastic Agents
Language	English
Publishing date	2023-01-16
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.13467
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Article: Focal and segmental glomerulosclerosis: varying biologic mechanisms underlie a final histopathologic end point.

Daskalakis, Nikki / Winn, Michelle P

Seminars in nephrology

2006 Volume 26, Issue 2, Page(s) 89–94

Abstract: Focal and segmental glomerulosclerosis (FSGS) is a pathologic entity that is a common and increasing cause of end-stage renal disease. Typical manifestations include proteinuria, hypertension, worsening renal insufficiency, and, frequently, renal failure. ...

Abstract	Focal and segmental glomerulosclerosis (FSGS) is a pathologic entity that is a common and increasing cause of end-stage renal disease. Typical manifestations include proteinuria, hypertension, worsening renal insufficiency, and, frequently, renal failure. The etiology, however, remains unknown in a majority of patients. There is an estimated recurrence rate of 30% to 40% in renal transplant patients, suggesting that the pathogenesis is not solely a result of intrinsic kidney disease. Although some of its characteristics have been reported, the precise identification of a circulating factor associated with FSGS has not been made. Remarkable progress has been made in recent years regarding biologic mechanisms surrounding FSGS and proteinuria. Insight into the pathogenesis of FSGS has been gained through the study of hereditary forms of FSGS and nephrotic syndromes. Mutations in cytoskeletal proteins that affect podocyte structure have been the target until recently. Here we review the current understanding of this glomerular disease and areas for future concentration.
MeSH term(s)	Adaptor Proteins, Signal Transducing ; Biomarkers/blood ; Cytoskeletal Proteins/blood ; Disease Progression ; Glomerulosclerosis, Focal Segmental/complications ; Glomerulosclerosis, Focal Segmental/metabolism ; Glomerulosclerosis, Focal Segmental/pathology ; Humans ; Intracellular Signaling Peptides and Proteins ; Kidney Failure, Chronic/etiology ; Kidney Failure, Chronic/pathology ; Membrane Proteins/blood ; Risk Factors ; TRPC Cation Channels/blood ; TRPC6 Cation Channel ; src Homology Domains
Chemical Substances	Adaptor Proteins, Signal Transducing ; Biomarkers ; CD2-associated protein ; Cytoskeletal Proteins ; Intracellular Signaling Peptides and Proteins ; Membrane Proteins ; NPHS2 protein ; TRPC Cation Channels ; TRPC6 Cation Channel ; TRPC6 protein, human ; nephrin
Language	English
Publishing date	2006-03
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	604652-6
ISSN	1558-4488 ; 0270-9295
ISSN (online)	1558-4488
ISSN	0270-9295
DOI	10.1016/j.semnephrol.2005.09.001
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Article ; Online: Disease-Drug Interaction of Sarilumab and Simvastatin in Patients with Rheumatoid Arthritis.

Lee, Eun Bong / Daskalakis, Nikki / Xu, Christine / Paccaly, Anne / Miller, Barry / Fleischmann, Roy / Bodrug, Inga / Kivitz, Alan

Clinical pharmacokinetics

2016 Volume 56, Issue 6, Page(s) 607–615

Abstract: Introduction: Elevated interleukin (IL)-6 occurs in patients with active rheumatoid arthritis (RA), which has been shown to lead to a decrease in cytochrome P450 (CYP) enzyme activity and alterations in drug concentrations metabolized by CYP. IL-6 ... ...

Abstract	Introduction: Elevated interleukin (IL)-6 occurs in patients with active rheumatoid arthritis (RA), which has been shown to lead to a decrease in cytochrome P450 (CYP) enzyme activity and alterations in drug concentrations metabolized by CYP. IL-6 signaling blockade by IL-6 receptor (IL-6R) antagonists may reverse this effect of IL-6 and restore CYP activity. This study evaluated the pharmacokinetic profile of simvastatin (a CYP3A4 substrate) before and 1 week after a single dose of sarilumab (a human monoclonal antibody [mAb] blocking the IL-6Rα) in patients with RA, to assess potential interaction. Methods: Nineteen patients with active RA received oral simvastatin 40 mg 1 day before and 7 days after subcutaneous injection of sarilumab 200 mg. The pharmacokinetic parameters of simvastatin and its primary metabolite, β-hydroxy-simvastatin acid, were calculated using noncompartmental analysis. Results: Compared with simvastatin alone, single-dose simvastatin administration 7 days after single-dose sarilumab administration in patients with RA resulted in reduced simvastatin and β-hydroxy-simvastatin acid exposure in plasma. Mean effect ratios (90 % confidence interval) for simvastatin peak plasma concentration (C Conclusions: Sarilumab treatment resulted in a reduction in exposure of simvastatin, consistent with reversal of IL-6-mediated CYP3A4 suppression in patients with active RA, as was reported for tocilizumab with simvastatin and for sirukumab with midazolam. Clinical trial registration number: NCT02017639.
MeSH term(s)	Adult ; Aged ; Antibodies, Monoclonal, Humanized/pharmacology ; Antirheumatic Agents/pharmacology ; Arthritis, Rheumatoid/blood ; Arthritis, Rheumatoid/drug therapy ; Arthritis, Rheumatoid/metabolism ; Cytochrome P-450 CYP3A/metabolism ; Drug Interactions ; Female ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/blood ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/pharmacokinetics ; Interleukin-6/antagonists & inhibitors ; Interleukin-6/blood ; Male ; Middle Aged ; Receptors, Interleukin-6/antagonists & inhibitors ; Receptors, Interleukin-6/blood ; Simvastatin/analogs & derivatives ; Simvastatin/blood ; Simvastatin/pharmacokinetics
Chemical Substances	Antibodies, Monoclonal, Humanized ; Antirheumatic Agents ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; IL6 protein, human ; IL6R protein, human ; Interleukin-6 ; Receptors, Interleukin-6 ; beta-hydroxy simvastatin acid ; Simvastatin (AGG2FN16EV) ; Cytochrome P-450 CYP3A (EC 1.14.14.1) ; sarilumab (NU90V55F8I)
Language	English
Publishing date	2016-10-08
Publishing country	Switzerland
Document type	Clinical Trial, Phase I ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	197627-8
ISSN	1179-1926 ; 0312-5963
ISSN (online)	1179-1926
ISSN	0312-5963
DOI	10.1007/s40262-016-0462-8
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Article: Unexpected role of TRPC6 channel in familial nephrotic syndrome: does it have clinical implications?

Winn, Michelle P / Daskalakis, Nikki / Spurney, Robert F / Middleton, John P

Journal of the American Society of Nephrology : JASN

2006 Volume 17, Issue 2, Page(s) 378–387

MeSH term(s)	Glomerulosclerosis, Focal Segmental/genetics ; Humans ; Mutation/genetics ; Nephrotic Syndrome/genetics ; Podocytes/physiology ; Receptors, Cell Surface/physiology ; TRPC Cation Channels/genetics ; TRPC Cation Channels/physiology ; TRPC6 Cation Channel
Chemical Substances	Receptors, Cell Surface ; TRPC Cation Channels ; TRPC6 Cation Channel ; TRPC6 protein, human
Language	English
Publishing date	2006-02
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1085942-1
ISSN	1533-3450 ; 1046-6673
ISSN (online)	1533-3450
ISSN	1046-6673
DOI	10.1681/ASN.2005090962
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Article ; Online: Clopidogrel pharmacodynamics and pharmacokinetics in the fed and fasted state: a randomized crossover study of healthy men.

Hurbin, Fabrice / Boulenc, Xavier / Daskalakis, Nikki / Farenc, Christine / Taylor, Theresa / Bonneau, Damien / Lacreta, Frank / Cheng, Sue / Sultan, Eric

Journal of clinical pharmacology

2012 Volume 52, Issue 10, Page(s) 1506–1515

Abstract: Clopidogrel requires CYP450-mediated hepatic metabolism to form its active metabolite (clopi-H4). This randomized, placebo-controlled, crossover study was designed to characterize the effect of a high-fat or standard breakfast on adenosine diphosphate ( ... ...

Abstract	Clopidogrel requires CYP450-mediated hepatic metabolism to form its active metabolite (clopi-H4). This randomized, placebo-controlled, crossover study was designed to characterize the effect of a high-fat or standard breakfast on adenosine diphosphate (ADP)-induced platelet aggregation and exposure to unchanged clopidogrel and clopi-H4 following clopidogrel (300-mg loading dose, 75 mg/d for 4 days) in 72 healthy men. At day 5 and as assessed by liquid chromatography-tandem mass spectrometry, unchanged clopidogrel area under the concentration- time curve from 0 to 24 hours (AUC(0-24)) increased 3.32-fold (90% confidence interval [CI], 2.88-3.84), and clopi-H4 AUC(0-24) decreased nonsignificantly by 12% (90% CI, 0.82-0.94) upon administration of clopidogrel with a standard breakfast. The estimated treatment difference in maximum platelet aggregation (MPA) induced by ADP 5 µM and assessed by light transmission aggregometry was 4.7%, with the 90% CI (0.9%-8.5%) contained within the prespecified equipotency range of ±15%. The mean ± standard deviation of day 5 inhibition of platelet aggregation was 49.7% ± 17.2% and 54.0% ± 13.3% in the fed and fasted states, respectively. Despite increased unchanged clopidogrel and slightly decreased clopi-H4 exposure following clopidogrel administration, the numerical increase in MPA in the fed versus fasted state was small and within the prespecified limit of equipotency. These findings confirm that clopidogrel can be taken with or without food.
MeSH term(s)	Adenosine Diphosphate ; Adult ; Area Under Curve ; Aryl Hydrocarbon Hydroxylases/genetics ; Breakfast ; Cross-Over Studies ; Cytochrome P-450 CYP2C19 ; Diet, High-Fat ; Food-Drug Interactions ; Genotype ; Humans ; Male ; Platelet Aggregation/drug effects ; Platelet Aggregation Inhibitors/administration & dosage ; Platelet Aggregation Inhibitors/blood ; Platelet Aggregation Inhibitors/pharmacokinetics ; Ticlopidine/administration & dosage ; Ticlopidine/analogs & derivatives ; Ticlopidine/blood ; Ticlopidine/pharmacokinetics ; Young Adult
Chemical Substances	Platelet Aggregation Inhibitors ; Adenosine Diphosphate (61D2G4IYVH) ; clopidogrel (A74586SNO7) ; Aryl Hydrocarbon Hydroxylases (EC 1.14.14.1) ; CYP2C19 protein, human (EC 1.14.14.1) ; Cytochrome P-450 CYP2C19 (EC 1.14.14.1) ; Ticlopidine (OM90ZUW7M1)
Language	English
Publishing date	2012-10
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	188980-1
ISSN	1552-4604 ; 0091-2700 ; 0021-9754
ISSN (online)	1552-4604
ISSN	0091-2700 ; 0021-9754
DOI	10.1177/0091270011419852
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Article ; Online: A mutation in the TRPC6 cation channel causes familial focal segmental glomerulosclerosis.

Winn, Michelle P / Conlon, Peter J / Lynn, Kelvin L / Farrington, Merry Kay / Creazzo, Tony / Hawkins, April F / Daskalakis, Nikki / Kwan, Shu Ying / Ebersviller, Seth / Burchette, James L / Pericak-Vance, Margaret A / Howell, David N / Vance, Jeffery M / Rosenberg, Paul B

Science (New York, N.Y.)

2005 Volume 308, Issue 5729, Page(s) 1801–1804

Abstract: Focal and segmental glomerulosclerosis (FSGS) is a kidney disorder of unknown etiology, and up to 20% of patients on dialysis have been diagnosed with it. Here we show that a large family with hereditary FSGS carries a missense mutation in the TRPC6 gene ...

Abstract	Focal and segmental glomerulosclerosis (FSGS) is a kidney disorder of unknown etiology, and up to 20% of patients on dialysis have been diagnosed with it. Here we show that a large family with hereditary FSGS carries a missense mutation in the TRPC6 gene on chromosome 11q, encoding the ion-channel protein transient receptor potential cation channel 6 (TRPC6). The proline-to-glutamine substitution at position 112, which occurs in a highly conserved region of the protein, enhances TRPC6-mediated calcium signals in response to agonists such as angiotensin II and appears to alter the intracellular distribution of TRPC6 protein. Previous work has emphasized the importance of cytoskeletal and structural proteins in proteinuric kidney diseases. Our findings suggest an alternative mechanism for the pathogenesis of glomerular disease.
MeSH term(s)	Amino Acid Substitution ; Angiotensin II/metabolism ; Angiotensin II/pharmacology ; Calcium/metabolism ; Calcium Channels/chemistry ; Calcium Channels/genetics ; Calcium Channels/metabolism ; Calcium Signaling ; Carbachol/pharmacology ; Cell Line ; Cell Membrane/metabolism ; Chromosomes, Human, Pair 11/genetics ; Exons ; Female ; GTP-Binding Protein alpha Subunits, Gq-G11/metabolism ; Glomerulosclerosis, Focal Segmental/genetics ; Haplotypes ; Humans ; Kidney/metabolism ; Kidney Glomerulus/metabolism ; Kidney Tubules/metabolism ; Male ; Mutation, Missense ; Patch-Clamp Techniques ; Pedigree ; Receptor, Angiotensin, Type 1/genetics ; Receptor, Angiotensin, Type 1/metabolism ; Sequence Analysis, DNA ; Sodium/metabolism ; TRPC Cation Channels ; TRPC6 Cation Channel ; Transfection ; Uridine Triphosphate/metabolism ; Uridine Triphosphate/pharmacology
Chemical Substances	Calcium Channels ; Receptor, Angiotensin, Type 1 ; TRPC Cation Channels ; TRPC6 Cation Channel ; TRPC6 protein, human ; Angiotensin II (11128-99-7) ; Carbachol (8Y164V895Y) ; Sodium (9NEZ333N27) ; GTP-Binding Protein alpha Subunits, Gq-G11 (EC 3.6.5.1) ; Calcium (SY7Q814VUP) ; Uridine Triphosphate (UT0S826Z60)
Language	English
Publishing date	2005-06-17
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	128410-1
ISSN	1095-9203 ; 0036-8075
ISSN (online)	1095-9203
ISSN	0036-8075
DOI	10.1126/science.1106215
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Article: A Mutation in the TRPC6 Cation Channel Causes Familial Focal Segmental Glomerulosclerosis

Winn, Michelle P / Burchette, James L / Conlon, Peter J / Creazzo, Tony / Daskalakis, Nikki / Ebersviller, Seth / Farrington, Merry Kay / Hawkins, April F / Howell, David N / Kwan, Shu Ying / Lynn, Kelvin L / Pericak-Vance, Margaret A / Rosenberg, Paul B / Vance, Jeffery M

Science. 2005 June 17, v. 308, no. 5729

2005

Abstract	Focal and segmental glomerulosclerosis (FSGS) is a kidney disorder of unknown etiology, and up to 20% of patients on dialysis have been diagnosed with it. Here we show that a large family with hereditary FSGS carries a missense mutation in the TRPC6 gene on chromosome 11q, encoding the ion-channel protein transient receptor potential cation channel 6 (TRPC6). The proline-to-glutamine substitution at position 112, which occurs in a highly conserved region of the protein, enhances TRPC6-mediated calcium signals in response to agonists such as angiotensin II and appears to alter the intracellular distribution of TRPC6 protein. Previous work has emphasized the importance of cytoskeletal and structural proteins in proteinuric kidney diseases. Our findings suggest an alternative mechanism for the pathogenesis of glomerular disease.
Keywords	agonists ; angiotensin II ; calcium signaling ; cations ; chromosomes ; cytoskeleton ; dialysis ; etiology ; genes ; kidney diseases ; kidneys ; missense mutation ; pathogenesis ; patients ; structural proteins
Language	English
Dates of publication	2005-0617
Size	p. 1801-1804.
Document type	Article
ZDB-ID	128410-1
ISSN	1095-9203 ; 0036-8075
ISSN (online)	1095-9203
ISSN	0036-8075
DOI	10.1126/science.1106215
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