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Article ; Online: Phase 1/2 Study of Lumasiran for Treatment of Primary Hyperoxaluria Type 1: A Placebo-Controlled Randomized Clinical Trial.

Frishberg, Yaacov / Deschênes, Georges / Groothoff, Jaap W / Hulton, Sally-Anne / Magen, Daniella / Harambat, Jérôme / Van't Hoff, William G / Lorch, Ulrike / Milliner, Dawn S / Lieske, John C / Haslett, Patrick / Garg, Pushkal P / Vaishnaw, Akshay K / Talamudupula, Sandeep / Lu, Jiandong / Habtemariam, Bahru A / Erbe, David V / McGregor, Tracy L / Cochat, Pierre

Clinical journal of the American Society of Nephrology : CJASN

2021 Volume 16, Issue 7, Page(s) 1025–1036

Abstract: Background and objectives: In the rare disease primary hyperoxaluria type 1, overproduction of oxalate by the liver causes kidney stones, nephrocalcinosis, kidney failure, and systemic oxalosis. Lumasiran, an RNA interference therapeutic, suppresses ... ...

Abstract	Background and objectives: In the rare disease primary hyperoxaluria type 1, overproduction of oxalate by the liver causes kidney stones, nephrocalcinosis, kidney failure, and systemic oxalosis. Lumasiran, an RNA interference therapeutic, suppresses glycolate oxidase, reducing hepatic oxalate production. The objective of this first-in-human, randomized, placebo-controlled trial was to evaluate the safety, pharmacokinetic, and pharmacodynamic profiles of lumasiran in healthy participants and patients with primary hyperoxaluria type 1. Design, setting, participants, & measurements: This phase 1/2 study was conducted in two parts. In part A, healthy adults randomized 3:1 received a single subcutaneous dose of lumasiran or placebo in ascending dose groups (0.3-6 mg/kg). In part B, patients with primary hyperoxaluria type 1 randomized 3:1 received up to three doses of lumasiran or placebo in cohorts of 1 or 3 mg/kg monthly or 3 mg/kg quarterly. Patients initially assigned to placebo crossed over to lumasiran on day 85. The primary outcome was incidence of adverse events. Secondary outcomes included pharmacokinetic and pharmacodynamic parameters, including measures of oxalate in patients with primary hyperoxaluria type 1. Data were analyzed using descriptive statistics. Results: Thirty-two healthy participants and 20 adult and pediatric patients with primary hyperoxaluria type 1 were enrolled. Lumasiran had an acceptable safety profile, with no serious adverse events or study discontinuations attributed to treatment. In part A, increases in mean plasma glycolate concentration, a measure of target engagement, were observed in healthy participants. In part B, patients with primary hyperoxaluria type 1 had a mean maximal reduction from baseline of 75% across dosing cohorts in 24-hour urinary oxalate excretion. All patients achieved urinary oxalate levels ≤1.5 times the upper limit of normal. Conclusions: Lumasiran had an acceptable safety profile and reduced urinary oxalate excretion in all patients with primary hyperoxaluria type 1 to near-normal levels. Clinical trial registry name and registration number: Study of Lumasiran in Healthy Adults and Patients with Primary Hyperoxaluria Type 1, NCT02706886.
MeSH term(s)	Adolescent ; Adult ; Child ; Female ; Glycolates/blood ; Humans ; Hyperoxaluria, Primary/blood ; Hyperoxaluria, Primary/drug therapy ; Hyperoxaluria, Primary/urine ; Male ; Oxalates/urine ; RNA, Small Interfering/adverse effects ; RNA, Small Interfering/pharmacokinetics ; RNA, Small Interfering/pharmacology ; Renal Agents/adverse effects ; Renal Agents/pharmacokinetics ; Renal Agents/pharmacology ; Single-Blind Method ; Young Adult
Chemical Substances	Glycolates ; Oxalates ; RNA, Small Interfering ; Renal Agents ; glycolic acid (0WT12SX38S) ; lumasiran (RZT8C352O1)
Language	English
Publishing date	2021-05-13
Publishing country	United States
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2226665-3
ISSN	1555-905X ; 1555-9041
ISSN (online)	1555-905X
ISSN	1555-9041
DOI	10.2215/CJN.14730920
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Article ; Online: Fibrin with Laminin-Nidogen Reduces Fibrosis and Improves Soft Palate Regeneration Following Palatal Injury.

Rosero Salazar, Doris H / van Rheden, René E M / van Hulzen, Manon / Carvajal Monroy, Paola L / Wagener, Frank A D T G / Von den Hoff, Johannes W

Biomolecules

2021 Volume 11, Issue 10

Abstract: This study aimed to analyze the effects of fibrin constructs enhanced with laminin-nidogen, implanted in the wounded rat soft palate. Fibrin constructs with and without laminin-nidogen were implanted in 1 mm excisional wounds in the soft palate of 9-week- ...

Abstract	This study aimed to analyze the effects of fibrin constructs enhanced with laminin-nidogen, implanted in the wounded rat soft palate. Fibrin constructs with and without laminin-nidogen were implanted in 1 mm excisional wounds in the soft palate of 9-week-old rats and compared with the wounded soft palate without implantation. Collagen deposition and myofiber formation were analyzed at days 3, 7, 28 and 56 after wounding by histochemistry. In addition, immune staining was performed for a-smooth muscle actin (a-SMA), myosin heavy chain (MyHC) and paired homeobox protein 7 (Pax7). At day 56, collagen areas were smaller in both implant groups (31.25 ± 7.73% fibrin only and 21.11 ± 6.06% fibrin with laminin-nidogen)) compared to the empty wounds (38.25 ± 8.89%,
MeSH term(s)	Actins/genetics ; Animals ; Collagen/genetics ; Fibrin/genetics ; Fibrin/pharmacology ; Fibrosis/genetics ; Fibrosis/pathology ; Fibrosis/therapy ; Humans ; Laminin/genetics ; Laminin/pharmacology ; Membrane Glycoproteins/genetics ; Membrane Glycoproteins/pharmacology ; Muscle, Skeletal/drug effects ; Muscle, Skeletal/growth & development ; Myofibrils/genetics ; Myosin Heavy Chains/genetics ; Paired Box Transcription Factors/genetics ; Palate, Soft/drug effects ; Palate, Soft/injuries ; Palate, Soft/pathology ; Rats ; Regeneration/genetics ; Wound Healing/genetics
Chemical Substances	Actins ; Laminin ; Membrane Glycoproteins ; PAX7 protein, rat ; Paired Box Transcription Factors ; nidogen ; smooth muscle actin, rat ; Fibrin (9001-31-4) ; Collagen (9007-34-5) ; Myosin Heavy Chains (EC 3.6.4.1)
Language	English
Publishing date	2021-10-19
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2701262-1
ISSN	2218-273X ; 2218-273X
ISSN (online)	2218-273X
ISSN	2218-273X
DOI	10.3390/biom11101547
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Article ; Online: MR Imaging and Clinical Characteristics of Diffuse Glioneuronal Tumor with Oligodendroglioma-like Features and Nuclear Clusters.

Benesch, M / Perwein, T / Apfaltrer, G / Langer, T / Neumann, A / Brecht, I B / Schuhmann, M U / Cario, H / Frühwald, M C / Vollert, K / van Buiren, M / Deng, M Y / Seitz, A / Haberler, C / Mynarek, M / Kramm, C / Sahm, F / Robe, P A / Dankbaar, J W /

Hoff, K V / Warmuth-Metz, M / Bison, B

AJNR. American journal of neuroradiology

2022 Volume 43, Issue 10, Page(s) 1523–1529

Abstract: Background and purpose: Diffuse glioneuronal tumor with oligodendroglioma-like features and nuclear clusters (DGONC) is a new, molecularly defined glioneuronal CNS tumor type. The objective of the present study was to describe MR imaging and clinical ... ...

Abstract	Background and purpose: Diffuse glioneuronal tumor with oligodendroglioma-like features and nuclear clusters (DGONC) is a new, molecularly defined glioneuronal CNS tumor type. The objective of the present study was to describe MR imaging and clinical characteristics of patients with DGONC. Materials and methods: Preoperative MR images of 9 patients with DGONC (median age at diagnosis, 9.9 years; range, 4.2-21.8 years) were reviewed. Results: All tumors were located superficially in the frontal/temporal lobes and sharply delineated, displaying little mass effect. Near the circle of Willis, the tumors encompassed the arteries. All except one demonstrated characteristics of low-to-intermediate aggressiveness with high-to-intermediate T2WI and ADC signals and bone remodeling. Most tumors ( Conclusions: This case series presents radiomorphologic characteristics highly predictive of DGONC that contrast with the typical aspects of the original histopathologic diagnoses. This presentation underlines the definition of DGONC as a separate entity, from a clinical perspective. Complete resection may be favorable for long-term disease control in patients with DGONC. The efficacy of nonsurgical treatment modalities should be evaluated in larger series.
MeSH term(s)	Humans ; Child ; Oligodendroglioma/diagnostic imaging ; Oligodendroglioma/surgery ; Glioma/pathology ; Central Nervous System Neoplasms/pathology ; Magnetic Resonance Imaging ; Neoplasms, Neuroepithelial ; Brain Neoplasms/diagnostic imaging ; Brain Neoplasms/therapy
Language	English
Publishing date	2022-09-22
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	603808-6
ISSN	1936-959X ; 0195-6108
ISSN (online)	1936-959X
ISSN	0195-6108
DOI	10.3174/ajnr.A7647
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Article: Fgf8a

Gebuijs, I G E / Raterman, S T / Metz, J R / Swanenberg, L / Zethof, J / Van den Bos, R / Carels, C E L / Wagener, F A D T G / Von den Hoff, J W

Biology open

2019 Volume 8, Issue 9

Abstract: Craniofacial development is tightly regulated and therefore highly vulnerable to disturbance by genetic and environmental factors. Fibroblast growth factors (FGFs) direct migration, proliferation and survival of cranial neural crest cells (CNCCs) forming ...

Abstract	Craniofacial development is tightly regulated and therefore highly vulnerable to disturbance by genetic and environmental factors. Fibroblast growth factors (FGFs) direct migration, proliferation and survival of cranial neural crest cells (CNCCs) forming the human face. In this study, we analyzed bone and cartilage formation in the head of five dpf
Language	English
Publishing date	2019-09-09
Publishing country	England
Document type	Journal Article
ZDB-ID	2632264-X
ISSN	2046-6390
ISSN	2046-6390
DOI	10.1242/bio.039834
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Article ; Online: Lumasiran, an RNAi Therapeutic for Primary Hyperoxaluria Type 1.

Garrelfs, Sander F / Frishberg, Yaacov / Hulton, Sally A / Koren, Michael J / O'Riordan, William D / Cochat, Pierre / Deschênes, Georges / Shasha-Lavsky, Hadas / Saland, Jeffrey M / Van't Hoff, William G / Fuster, Daniel G / Magen, Daniella / Moochhala, Shabbir H / Schalk, Gesa / Simkova, Eva / Groothoff, Jaap W / Sas, David J / Meliambro, Kristin A / Lu, Jiandong /

Sweetser, Marianne T / Garg, Pushkal P / Vaishnaw, Akshay K / Gansner, John M / McGregor, Tracy L / Lieske, John C

The New England journal of medicine

2021 Volume 384, Issue 13, Page(s) 1216–1226

Abstract: Background: Primary hyperoxaluria type 1 (PH1) is a rare genetic disease caused by hepatic overproduction of oxalate that leads to kidney stones, nephrocalcinosis, kidney failure, and systemic oxalosis. Lumasiran, an investigational RNA interference ( ... ...

Abstract	Background: Primary hyperoxaluria type 1 (PH1) is a rare genetic disease caused by hepatic overproduction of oxalate that leads to kidney stones, nephrocalcinosis, kidney failure, and systemic oxalosis. Lumasiran, an investigational RNA interference (RNAi) therapeutic agent, reduces hepatic oxalate production by targeting glycolate oxidase. Methods: In this double-blind, phase 3 trial, we randomly assigned (in a 2:1 ratio) patients with PH1 who were 6 years of age or older to receive subcutaneous lumasiran or placebo for 6 months (with doses given at baseline and at months 1, 2, 3, and 6). The primary end point was the percent change in 24-hour urinary oxalate excretion from baseline to month 6 (mean percent change across months 3 through 6). Secondary end points included the percent change in the plasma oxalate level from baseline to month 6 (mean percent change across months 3 through 6) and the percentage of patients with 24-hour urinary oxalate excretion no higher than 1.5 times the upper limit of the normal range at month 6. Results: A total of 39 patients underwent randomization; 26 were assigned to the lumasiran group and 13 to the placebo group. The least-squares mean difference in the change in 24-hour urinary oxalate excretion (lumasiran minus placebo) was -53.5 percentage points (P<0.001), with a reduction in the lumasiran group of 65.4% and an effect seen as early as month 1. The between-group differences for all hierarchically tested secondary end points were significant. The difference in the percent change in the plasma oxalate level (lumasiran minus placebo) was -39.5 percentage points (P<0.001). In the lumasiran group, 84% of patients had 24-hour urinary oxalate excretion no higher than 1.5 times the upper limit of the normal range at month 6, as compared with 0% in the placebo group (P<0.001). Mild, transient injection-site reactions were reported in 38% of lumasiran-treated patients. Conclusions: Lumasiran reduced urinary oxalate excretion, the cause of progressive kidney failure in PH1. The majority of patients who received lumasiran had normal or near-normal levels after 6 months of treatment. (Funded by Alnylam Pharmaceuticals; ILLUMINATE-A ClinicalTrials.gov number, NCT03681184.).
MeSH term(s)	Adolescent ; Adult ; Child ; Creatinine/urine ; Double-Blind Method ; Female ; Glomerular Filtration Rate ; Humans ; Hyperoxaluria, Primary/blood ; Hyperoxaluria, Primary/complications ; Hyperoxaluria, Primary/drug therapy ; Hyperoxaluria, Primary/urine ; Kidney Calculi/prevention & control ; Male ; Middle Aged ; Oxalates/blood ; Oxalates/metabolism ; Oxalates/urine ; RNA, Small Interfering/adverse effects ; RNA, Small Interfering/therapeutic use ; RNAi Therapeutics ; Young Adult
Chemical Substances	Oxalates ; RNA, Small Interfering ; Creatinine (AYI8EX34EU) ; lumasiran (RZT8C352O1)
Language	English
Publishing date	2021-03-31
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2021712
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Article ; Online: Molecular developments in renal tubulopathies.

Van'T Hoff, W G

Archives of disease in childhood

2000 Volume 83, Issue 3, Page(s) 189–191

MeSH term(s)	Acidosis, Renal Tubular/diagnosis ; Acidosis, Renal Tubular/genetics ; Bartter Syndrome/diagnosis ; Bartter Syndrome/genetics ; Child ; Diabetes Insipidus, Nephrogenic/diagnosis ; Diabetes Insipidus, Nephrogenic/genetics ; Fanconi Syndrome/diagnosis ; Fanconi Syndrome/genetics ; Humans ; Kidney Diseases/diagnosis ; Kidney Diseases/genetics ; Kidney Diseases/urine ; Kidney Tubules, Distal ; Kidney Tubules, Proximal ; Mutation/genetics ; Phenotype ; Pseudohypoaldosteronism/diagnosis ; Pseudohypoaldosteronism/genetics
Language	English
Publishing date	2000-03-21
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	524-1
ISSN	1468-2044 ; 0003-9888 ; 1359-2998
ISSN (online)	1468-2044
ISSN	0003-9888 ; 1359-2998
DOI	10.1136/adc.83.3.189
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Um IV Zs.106: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Modal shift in North Atlantic seasonality during the last deglaciation

G.-J. A. Brummer / B. Metcalfe / W. Feldmeijer / M. A. Prins / J. van 't Hoff / G. M. Ganssen

Climate of the Past, Vol 16, Pp 265-

2020 Volume 282

Abstract: ... of pooled N. pachyderma and G. bulloides shells shows a warming trend concurrent with the retreating ice ... in a bimodal seasonal succession, separated by the subpolar G. bulloides . This represents a shift ... whilst G. bulloides with a greater tolerance to higher temperatures persisted throughout the Holocene ...

Abstract	Changeover from a glacial to an interglacial climate is considered as transitional between two stable modes. Palaeoceanographic reconstructions using the polar foraminifera Neogloboquadrina pachyderma highlight the retreat of the Polar Front during the last deglaciation in terms of both its decreasing abundance and stable oxygen isotope values ( δ 18 O ) in sediment cores. While conventional isotope analysis of pooled N. pachyderma and G. bulloides shells shows a warming trend concurrent with the retreating ice, new single-shell measurements reveal that this trend is composed of two isotopically different populations that are morphologically indistinguishable. Using modern time series as analogues for interpreting downcore data, glacial productivity in the mid-North Atlantic appears limited to a single maximum in late summer, followed by the melting of drifting icebergs and winter sea ice. Despite collapsing ice sheets and global warming during the deglaciation, a second “warm” population of N. pachyderma appears in a bimodal seasonal succession, separated by the subpolar G. bulloides . This represents a shift in the timing of the main plankton bloom from late to early summer in a “deglacial” intermediate mode that persisted from the glacial maximum until the start of the Holocene. When seawater temperatures exceeded the threshold values, first the “cold” (glacial) then the “warm” (deglacial) populations of N. pachyderma disappeared, whilst G. bulloides with a greater tolerance to higher temperatures persisted throughout the Holocene to the present day in the midlatitude North Atlantic. Single-specimen δ 18 O of polar N. pachyderma reveals a steeper rate of ocean warming during the last deglaciation than appears from conventional pooled δ 18 O average values.
Keywords	Environmental pollution ; TD172-193.5 ; Environmental protection ; TD169-171.8 ; Environmental sciences ; GE1-350
Subject code	333
Language	English
Publishing date	2020-02-01T00:00:00Z
Publisher	Copernicus Publications
Document type	Article ; Online
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Article ; Online: Fibrin with Laminin-Nidogen Reduces Fibrosis and Improves Soft Palate Regeneration Following Palatal Injury

Doris H. Rosero Salazar / René E. M. van Rheden / Manon van Hulzen / Paola L. Carvajal Monroy / Frank A. D. T. G. Wagener / Johannes W. Von den Hoff

Biomolecules, Vol 11, Iss 1547, p

2021 Volume 1547

Abstract	This study aimed to analyze the effects of fibrin constructs enhanced with laminin-nidogen, implanted in the wounded rat soft palate. Fibrin constructs with and without laminin-nidogen were implanted in 1 mm excisional wounds in the soft palate of 9-week-old rats and compared with the wounded soft palate without implantation. Collagen deposition and myofiber formation were analyzed at days 3, 7, 28 and 56 after wounding by histochemistry. In addition, immune staining was performed for a-smooth muscle actin (a-SMA), myosin heavy chain (MyHC) and paired homeobox protein 7 (Pax7). At day 56, collagen areas were smaller in both implant groups (31.25 ± 7.73% fibrin only and 21.11 ± 6.06% fibrin with laminin-nidogen)) compared to the empty wounds (38.25 ± 8.89%, p < 0.05). Moreover, the collagen area in the fibrin with laminin-nidogen group was smaller than in the fibrin only group ( p ˂ 0.05). The areas of myofiber formation in the fibrin only group (31.77 ± 10.81%) and fibrin with laminin-nidogen group (43.13 ± 10.39%) were larger than in the empty wounds (28.10 ± 11.68%, p ˂ 0.05). Fibrin-based constructs with laminin-nidogen reduce fibrosis and improve muscle regeneration in the wounded soft palate. This is a promising strategy to enhance cleft soft palate repair and other severe muscle injuries.
Keywords	fibrin ; soft palate ; cleft palate ; skeletal muscle ; nidogen ; regenerative medicine ; Microbiology ; QR1-502
Language	English
Publishing date	2021-10-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
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Article: Biology and genetics of inherited renal tubular disorders.

van't Hoff, W G

Experimental nephrology

1996 Volume 4, Issue 5, Page(s) 253–262

MeSH term(s)	Acidosis, Renal Tubular/genetics ; Acidosis, Renal Tubular/physiopathology ; Animals ; Bartter Syndrome/genetics ; Bartter Syndrome/physiopathology ; Carbonic Anhydrases/deficiency ; Congenital Abnormalities/genetics ; Cystinuria/genetics ; Cystinuria/physiopathology ; Diabetes Insipidus, Nephrogenic/genetics ; Diabetes Insipidus, Nephrogenic/physiopathology ; Disease Models, Animal ; Fanconi Syndrome/genetics ; Fanconi Syndrome/physiopathology ; Female ; Humans ; Hypophosphatemia, Familial/genetics ; Hypophosphatemia, Familial/physiopathology ; Kidney Diseases/genetics ; Kidney Diseases/physiopathology ; Kidney Tubules/abnormalities ; Kidney Tubules/physiopathology ; Male ; Pseudohypoaldosteronism/genetics ; Pseudohypoaldosteronism/physiopathology ; Syndrome
Chemical Substances	Carbonic Anhydrases (EC 4.2.1.1)
Language	English
Publishing date	1996-09
Publishing country	Switzerland
Document type	Editorial ; Review
ZDB-ID	1141471-6
ISSN	1421-9956 ; 1018-7782
ISSN (online)	1421-9956
ISSN	1018-7782
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Article: Erratum: Long-term outcome in inherited nephrogenic diabetes insipidus.

Sharma, Sonia / Ashton, Emma / Iancu, Daniela / Arthus, Marie-Francoise / Hayes, Wesley / Van't Hoff, William / Kleta, Robert / Bichet, Daniel G / Bockenhauer, Detlef

Clinical kidney journal

2020 Volume 13, Issue 6, Page(s) 1111

Abstract: This corrects the article DOI: 10.1093/ckj/sfy027.][This corrects the article DOI: 10.1093/ckj/sfy027.]. ...

Abstract	[This corrects the article DOI: 10.1093/ckj/sfy027.][This corrects the article DOI: 10.1093/ckj/sfy027.].
Language	English
Publishing date	2020-12-07
Publishing country	England
Document type	Published Erratum
ZDB-ID	2655800-2
ISSN	2048-8513 ; 2048-8505
ISSN (online)	2048-8513
ISSN	2048-8505
DOI	10.1093/ckj/sfaa223
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